Author's Accepted Manuscript
Vitamin D Supplementation: Not so Simple in Sarcoidosis Amik Sodhi MBBS, MPH, FCCP, Thomas Aldrich MD
www.amjmedsci.com
PII: DOI: Reference:
S0002-9629(16)30293-2 http://dx.doi.org/10.1016/j.amjms.2016.05.027 AMJMS208
To appear in:
Am J Med Sci
Received date: 1 March 2016 Revised date: 24 May 2016 Accepted date: 25 May 2016 Cite this article as: Amik Sodhi MBBS, MPH, FCCP, Thomas Aldrich MD, Vitamin D Supplementation: Not so Simple in Sarcoidosis, Am J Med Sci, http://dx.doi.org/ 10.1016/j.amjms.2016.05.027 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
VITAMIN D SUPPLEMENTATION: NOT SO SIMPLE IN SARCOIDOSIS Amik Sodhi1 MBBS, MPH, FCCP; Thomas Aldrich1 MD
Institution: 1- Division of Pulmonary Medicine, Montefiore Medical Center & Albert Einstein College of Medicine, 111 E 210th Street, Bronx, NY 10467
Short Title: Vitamin D supplementation in Sarcoidosis
Correspondence & reprints(Current Institution of Author): Amik Sodhi MBBS, MPH, FCCP Assistant Professor, Pulmonary, Critical Care and Sleep Medicine University of Tennessee Health Science Center 956 Court Ave, Room G-228, Memphis, TN 38163 Phone: (901) 448-5757; FAX: (901) 448-7726 E-mail: [email protected] No financial support was used, No conflict of interest exists.
1
Abbreviations: 25-OH-vit D :
25-Hydroxy-Vitamin D
1,25-OH-vit D :
1,25-dihydroxy-Vitamin D
US :
United States
ACE :
Angiotensin Converting Enzyme
PTH :
Parathyroid Hormone
ACCESS:
A Case Control Etiologic Study of Sarcoidosis
EMR:
Electronic Medical Record
Abstract: Introduction: Americans are increasingly receiving vitamin D supplementation, often based on low measured 25-hydroxy-vitamin D (25-OH-vit D). In sarcoidosis there is often increased metabolism of 25-OH-vit D to 1,25-dihydroxy-vitamin D (1,25-OH-vit D), so 25-OH-vit D may remain low, despite high levels of 1,25-OH-vit D. In such cases, vitamin D supplementation may lead to hypercalcemia. Methods: We randomly selected 196 sarcoidosis patients who received at least one prescription of vitamin D between 2005 and 2011 and 196 control patients. Primary outcome was the incidence of hypercalcemia during the 2 years following the vitamin D prescription. A secondary outcome was the proportion of patients that had received vitamin D prescriptions who had adequate blood-work performed prior to the prescription.
2
Results: 25-OH-vit D and 1,25-OH-vit D levels were measured in only 70% and 23% of those receiving supplementation. Hypercalcemia was noted more frequently in the group that received Vitamin D (42.3% ) as compared to the non supplemented group (18.3%), p < 0.0001. Patients who received a vitamin D prescription developed moderate and severe hypercalcemia more frequently (12.8%) as compared to the group that did not receive Vitamin D (3.6%), p 0.001. In multivariate analysis, having a prescription for Vitamin D increased the risk of developing of hypercalcemia about 2 fold. Renal failure also increased the risk of developing hypercalcemia (OR 4.1). Conclusions: Our study demonstrates that a substantial proportion of sarcoidosis patients who receive vitamin D are not getting appropriate pre testing. This increases their risk for developing hypercalcemia.
MeSH Keywords: Vitamin D, Sarcoidosis, Hypercalcemia
Introduction Vitamin D insufficiency, diagnosed as 25-hydroxy vitamin D (25-OH-vit D) < 30 ng/ml, is increasingly being recognized in the United States (US) population. Its prevalence increased from 56% in 1989-94 to 77% in 2001-2004[1]. One consequence has been increased reported use of vitamin D supplements by women over 60 years of age, up from 30 % to 56% [2]. Following a similar trend, in the Nurses’ Health Study, usage of vitamin D supplements increased from 4.2% in 1986 to 32.2% in 2006 [3].
3
Sarcoidosis is a relatively common granulomatous inflammatory condition of unknown cause, potentially affecting any organ, most commonly lymph nodes, skin, eyes, joints and lungs. Abnormal calcium metabolism is a common but not universal feature of sarcoidosis. Reports suggest hypercalcemia occurs in 2-27% of patients with this disease [4,5,6,7,8], with perhaps the most reliable estimate at 11% [9]. The largest case control study in sarcoidosis, A Case Control Etiologic Study Of Sarcoidosis (ACCESS) study had 736 patients with sarcodosis, of whom 3.7% developed hypercalcemia over a 2 year period [10]. More recently, a cohort of 1606 patients with sarcoidosis from the University of Cincinnati had a 6% incidence of hypercalcemia and 23% of patients reported a present or previous history of hypercalcemia [11]. Hypercalciuria occurs more frequently, with reports upto 67% [12]. The etiology for elevated calcium levels is, in most cases, excessive levels of 1,25 dihydroxy vitamin D (1,25-OHvit D), produced by conversion of 25-OH-vit D to 1,25-OH-vit D, by the sarcoid granulomas [13]. Sarcoidosis is considered a contraindication for high-dose vitamin D supplementation [13], but, because 25-OH-vit D levels are often low, despite high levels of the active metabolite 1,25-OHvit D, and because supplementary vitamin D is generally considered harmless and unselectively recommended by many doctors and nutritionists, it is possible that sarcoidosis patients are receiving inappropriate vitamin D supplementation. Dr Baughman and colleagues reported that out of 261 patients with sarcoidosis, 83.5% had low levels of 25-OH-vit D [11] and more than 70% of the patients that had a low 25-OH-vit D level had an elevated 1,25-OH-vit D level. Similarly, in a study of bone health in 142 patients with sarcoidosis, about 75% of patients had 25-OH-vit D levels less than 20 ng/ml and the mean 25 OH-vit D level was 14.5 ng/ml [14]. Both these studies suggest that if vitamin D supplementation is based solely on the 25-OH-vit D level
4
in patients with sarcoidosis, a fairly large percentage of sarcoid patients would receive vitamin D supplementation. A possible consequence could be increased incidence of renal and salivary stones and of clinically significant hypercalcemia. This study aimed to delineate vitamin D prescription practices among patients with sarcoidosis seen at outpatient clinics in and around Bronx, New York and clinical consequences that may arise as a result of such practices. We also wanted to explore demographic and various clinical factors that may increase the risk of hypercalcemic adverse effects in this group of patients.
Materials and Methods: Study Design The study collected data from a retrospective cohort of patients diagnosed with sarcoidosis who had at least one clinical outpatient visit for their sarcoidosis at the outpatient clinics affiliated with Montefiore Medical Center, Bronx, New York between January 1st 2005 and December 31st 2011. Patients had to be 18 years of age or older, have had at least one clinical visit for sarcoidosis during the study period and have had at least one serum calcium level drawn during the study period. Patients were required to have been diagnosed with sarcoidosis for at least a year prior to the clinic visit. Patients with no serum calcium levels during the defined period were excluded. Patients known to have alternative reasons for hypercalcemia (multiple myeloma, metastatic cancer with bony metastases, hyperparathyroidism) were also excluded. Clinical events in the 2 years after initial prescription (in the vitamin D supplemented
5
group) or 2 years after first contact during study period(in the non supplemented group) were recorded. The study was approved by the Albert Einstein College of Medicine IRB (under Protocol No 1201-010E). Methodology The retrospective cohort was generated using Clinical Looking Glass, Montefiore Medical Center’s clinical data aggregation software. Patients meeting the inclusion criteria were divided into two groups based on whether they received a prescription for vitamin D during the study period or not. Among 1882 patients who met the inclusion criteria, 405 patients did and 1407 did not receive vitamin D prescriptions during the study period. Charts were then selected at random (with the aid of a random number table) within the two groups for detailed review, to verify the accuracy of the inclusion and exclusion criteria, to verify prescribed vitamin D doses, and to determine clinical outcome. 520 charts were reviewed in detail. 128 patients were excluded as they either did not meet inclusion criteria as defined above on detailed review or met exclusion criteria. The final analysis included 196 patients with sarcoidosis who had received at least one vitamin D prescription during the study period (henceforth called Group D) and 196 patients with sarcoidosis who did not receive any Vitamin D prescriptions during the study period (henceforth called Group S). Vitamin D deficiency was defined as a 25-OH-vit D level of less than 20 ng/ml and vitamin D insufficiency was defined as a 25-OH-vit D level between 20ng/ml and 30 ng/ml. 1,25-OH-vit D levels were considered normal if they were between 10 pg/ml and 75 pg/ml. We extracted details from the vitamin D prescriptions to determine approximate daily dose and length of
6
treatment. The patients were divided into 3 groups based on the daily vitamin D dose (low dose < 1000 units per day; moderate dose 1000 to 4000 units per day; high dose > 4000 units per day). Details about steroid therapy in the 3 months preceding a hypercalcemia event were also noted. Patients were classified as taking no steroids, low dose steroids(less than or equal to 15 mg equivalent prednisone per day) or high dose steroids(more than 15 mg prednisone per day for more than 2 weeks). Renal failure was defined as serum Creatinine > 1.1 mg/dl in females and > 1.2 mg/dl in males. Primary Outcome The primary outcome was the prevalence of any detected hypercalcemia (symptomatic or asymptomatic) that may or may not have required hospitalization during the first 2 years after initial contact (Group S) or 2 years after the first prescription (Group D). Hypercalcemia was defined as calcium levels greater than 10.2 mg/dl. Mild hypercalcemia was defined as calcium levels between 10.2 mg/dl and 11.9 mg/dl. Calcium levels greater than or equal to 12 were defined as moderate to severe hypercalcemia. Secondary Outcomes A secondary outcome was the proportion of patients that had received vitamin D prescriptions who had adequate blood work performed prior to the prescription.
Data Analysis: We assumed a rate of hypercalcemia of 11%, based on the published literature [9]. In order to detect a 10% difference in hypercalcemic complication rates between the 2 groups we estimated a total sample size of 505, based on a power of 80% and alpha of 0.05.
7
The data were analysed using SPSS software (Version 21). For univariate analysis of categorical data we used chi square test. For univariate analysis of continuous data Students t-test was used. For multivariate analyses, multivariate logistic regression analysis was used.
Results: Demographic features of both groups are listed in Table 1. Both groups were approximately 50% female, predominantly African American and had similar mean age. Approximately 25% of patients in each group were on steroids in the 3 months preceding their highest calcium level. The proportion of patients with renal failure was similar in both groups, as was the median Angiotensin Converting Enzyme (ACE) level. Majority (> 80%) of the patients were seen and followed by primary care providers and did not see a pulmonologist within the hospital system during the 2 years. 25 hydroxy vitamin D (25-OH-vit D) level testing Only 69.9% of the patients prescribed a vitamin D supplement had 25-OH-vit D levels tested prior to the prescription. As expected, levels of testing were significantly lower in Group S (29.1%). (Table 2) 1,25 Dihydroxy vitamin D (1,25-OH-vit D) level testing Only 23% of patients given a vitamin D prescription had 1,25-OH-vit D levels tested prior to the prescription. As expected, the proportion of patients receiving this test was significantly lower in Group S (5.1%). (Table 2)
8
Vitamin D prescription details Sixty percent of the patients received low dose vitamin D supplementation, 16.8% received moderate vitamin D supplementation and 23% received high dose vitamin D supplementation. The mean duration of supplementation was 1.3 years. Forty percent of the patients had the therapy discontinued at some point during the study period. Vitamin D Deficiency Based on 25-OH-vit D levels 47.4%, 13.7% and 10.5% patients in Group D were classified as having vitamin D deficiency, vitamin D insufficiency and normal vitamin D levels respectively. 30% patients had no measurement of 25-OH-vit D. In Group S, 10.8% 11.9% and 6.7% were classified as having vitamin D deficiency, vitamin D insufficiency and normal vitamin D levels respectively. 71% of patients did not have 25-OH-vit D levels tested in this group. Based on 1,25-OH-vit D levels 4.1% patients in Group D were diagnosed as having true vitamin D deficiency. In the same group, 10.2% had normal 1,25-OH-vit D levels, 8.7% had high 1,25OH-vit D levels and 77% had no 1,25-OH-vit D levels tested. In Group S, 95% of the patients did not have 1,25-OH-vit D levels tested. Appropriate Lab work prior to vitamin D prescription Patients who either did not have 1,25-OH-vit D levels measured or had normal or high levels of 1,25-OH-vit D prior to a vitamin D prescription were labeled as not having appropriate lab work prior to prescription. Approximately 87% of patients in Group D did not have appropriate lab work prior to their prescription. This was seen across all prescription strengths of vitamin D (Table 3).
9
Fifty two percent of patients in Group D either did not have a 25-OH-vit D level measured or were given prescriptions despite normal levels of 25-OH-Vit D. This was particularly seen in the group of patients that received low dose vitamin D (75%) and less so in the high dose group (10%).
Hypercalcemia Hypercalcemia occurred more frequently in Group D as compared to Group S (42.3% and 18.3% respectively, p
Vitamin D Supplementation: Not so Simple in Sarcoidosis Amik Sodhi MBBS, MPH, FCCP, Thomas Aldrich MD
www.amjmedsci.com
PII: DOI: Reference:
S0002-9629(16)30293-2 http://dx.doi.org/10.1016/j.amjms.2016.05.027 AMJMS208
To appear in:
Am J Med Sci
Received date: 1 March 2016 Revised date: 24 May 2016 Accepted date: 25 May 2016 Cite this article as: Amik Sodhi MBBS, MPH, FCCP, Thomas Aldrich MD, Vitamin D Supplementation: Not so Simple in Sarcoidosis, Am J Med Sci, http://dx.doi.org/ 10.1016/j.amjms.2016.05.027 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
VITAMIN D SUPPLEMENTATION: NOT SO SIMPLE IN SARCOIDOSIS Amik Sodhi1 MBBS, MPH, FCCP; Thomas Aldrich1 MD
Institution: 1- Division of Pulmonary Medicine, Montefiore Medical Center & Albert Einstein College of Medicine, 111 E 210th Street, Bronx, NY 10467
Short Title: Vitamin D supplementation in Sarcoidosis
Correspondence & reprints(Current Institution of Author): Amik Sodhi MBBS, MPH, FCCP Assistant Professor, Pulmonary, Critical Care and Sleep Medicine University of Tennessee Health Science Center 956 Court Ave, Room G-228, Memphis, TN 38163 Phone: (901) 448-5757; FAX: (901) 448-7726 E-mail: [email protected] No financial support was used, No conflict of interest exists.
1
Abbreviations: 25-OH-vit D :
25-Hydroxy-Vitamin D
1,25-OH-vit D :
1,25-dihydroxy-Vitamin D
US :
United States
ACE :
Angiotensin Converting Enzyme
PTH :
Parathyroid Hormone
ACCESS:
A Case Control Etiologic Study of Sarcoidosis
EMR:
Electronic Medical Record
Abstract: Introduction: Americans are increasingly receiving vitamin D supplementation, often based on low measured 25-hydroxy-vitamin D (25-OH-vit D). In sarcoidosis there is often increased metabolism of 25-OH-vit D to 1,25-dihydroxy-vitamin D (1,25-OH-vit D), so 25-OH-vit D may remain low, despite high levels of 1,25-OH-vit D. In such cases, vitamin D supplementation may lead to hypercalcemia. Methods: We randomly selected 196 sarcoidosis patients who received at least one prescription of vitamin D between 2005 and 2011 and 196 control patients. Primary outcome was the incidence of hypercalcemia during the 2 years following the vitamin D prescription. A secondary outcome was the proportion of patients that had received vitamin D prescriptions who had adequate blood-work performed prior to the prescription.
2
Results: 25-OH-vit D and 1,25-OH-vit D levels were measured in only 70% and 23% of those receiving supplementation. Hypercalcemia was noted more frequently in the group that received Vitamin D (42.3% ) as compared to the non supplemented group (18.3%), p < 0.0001. Patients who received a vitamin D prescription developed moderate and severe hypercalcemia more frequently (12.8%) as compared to the group that did not receive Vitamin D (3.6%), p 0.001. In multivariate analysis, having a prescription for Vitamin D increased the risk of developing of hypercalcemia about 2 fold. Renal failure also increased the risk of developing hypercalcemia (OR 4.1). Conclusions: Our study demonstrates that a substantial proportion of sarcoidosis patients who receive vitamin D are not getting appropriate pre testing. This increases their risk for developing hypercalcemia.
MeSH Keywords: Vitamin D, Sarcoidosis, Hypercalcemia
Introduction Vitamin D insufficiency, diagnosed as 25-hydroxy vitamin D (25-OH-vit D) < 30 ng/ml, is increasingly being recognized in the United States (US) population. Its prevalence increased from 56% in 1989-94 to 77% in 2001-2004[1]. One consequence has been increased reported use of vitamin D supplements by women over 60 years of age, up from 30 % to 56% [2]. Following a similar trend, in the Nurses’ Health Study, usage of vitamin D supplements increased from 4.2% in 1986 to 32.2% in 2006 [3].
3
Sarcoidosis is a relatively common granulomatous inflammatory condition of unknown cause, potentially affecting any organ, most commonly lymph nodes, skin, eyes, joints and lungs. Abnormal calcium metabolism is a common but not universal feature of sarcoidosis. Reports suggest hypercalcemia occurs in 2-27% of patients with this disease [4,5,6,7,8], with perhaps the most reliable estimate at 11% [9]. The largest case control study in sarcoidosis, A Case Control Etiologic Study Of Sarcoidosis (ACCESS) study had 736 patients with sarcodosis, of whom 3.7% developed hypercalcemia over a 2 year period [10]. More recently, a cohort of 1606 patients with sarcoidosis from the University of Cincinnati had a 6% incidence of hypercalcemia and 23% of patients reported a present or previous history of hypercalcemia [11]. Hypercalciuria occurs more frequently, with reports upto 67% [12]. The etiology for elevated calcium levels is, in most cases, excessive levels of 1,25 dihydroxy vitamin D (1,25-OHvit D), produced by conversion of 25-OH-vit D to 1,25-OH-vit D, by the sarcoid granulomas [13]. Sarcoidosis is considered a contraindication for high-dose vitamin D supplementation [13], but, because 25-OH-vit D levels are often low, despite high levels of the active metabolite 1,25-OHvit D, and because supplementary vitamin D is generally considered harmless and unselectively recommended by many doctors and nutritionists, it is possible that sarcoidosis patients are receiving inappropriate vitamin D supplementation. Dr Baughman and colleagues reported that out of 261 patients with sarcoidosis, 83.5% had low levels of 25-OH-vit D [11] and more than 70% of the patients that had a low 25-OH-vit D level had an elevated 1,25-OH-vit D level. Similarly, in a study of bone health in 142 patients with sarcoidosis, about 75% of patients had 25-OH-vit D levels less than 20 ng/ml and the mean 25 OH-vit D level was 14.5 ng/ml [14]. Both these studies suggest that if vitamin D supplementation is based solely on the 25-OH-vit D level
4
in patients with sarcoidosis, a fairly large percentage of sarcoid patients would receive vitamin D supplementation. A possible consequence could be increased incidence of renal and salivary stones and of clinically significant hypercalcemia. This study aimed to delineate vitamin D prescription practices among patients with sarcoidosis seen at outpatient clinics in and around Bronx, New York and clinical consequences that may arise as a result of such practices. We also wanted to explore demographic and various clinical factors that may increase the risk of hypercalcemic adverse effects in this group of patients.
Materials and Methods: Study Design The study collected data from a retrospective cohort of patients diagnosed with sarcoidosis who had at least one clinical outpatient visit for their sarcoidosis at the outpatient clinics affiliated with Montefiore Medical Center, Bronx, New York between January 1st 2005 and December 31st 2011. Patients had to be 18 years of age or older, have had at least one clinical visit for sarcoidosis during the study period and have had at least one serum calcium level drawn during the study period. Patients were required to have been diagnosed with sarcoidosis for at least a year prior to the clinic visit. Patients with no serum calcium levels during the defined period were excluded. Patients known to have alternative reasons for hypercalcemia (multiple myeloma, metastatic cancer with bony metastases, hyperparathyroidism) were also excluded. Clinical events in the 2 years after initial prescription (in the vitamin D supplemented
5
group) or 2 years after first contact during study period(in the non supplemented group) were recorded. The study was approved by the Albert Einstein College of Medicine IRB (under Protocol No 1201-010E). Methodology The retrospective cohort was generated using Clinical Looking Glass, Montefiore Medical Center’s clinical data aggregation software. Patients meeting the inclusion criteria were divided into two groups based on whether they received a prescription for vitamin D during the study period or not. Among 1882 patients who met the inclusion criteria, 405 patients did and 1407 did not receive vitamin D prescriptions during the study period. Charts were then selected at random (with the aid of a random number table) within the two groups for detailed review, to verify the accuracy of the inclusion and exclusion criteria, to verify prescribed vitamin D doses, and to determine clinical outcome. 520 charts were reviewed in detail. 128 patients were excluded as they either did not meet inclusion criteria as defined above on detailed review or met exclusion criteria. The final analysis included 196 patients with sarcoidosis who had received at least one vitamin D prescription during the study period (henceforth called Group D) and 196 patients with sarcoidosis who did not receive any Vitamin D prescriptions during the study period (henceforth called Group S). Vitamin D deficiency was defined as a 25-OH-vit D level of less than 20 ng/ml and vitamin D insufficiency was defined as a 25-OH-vit D level between 20ng/ml and 30 ng/ml. 1,25-OH-vit D levels were considered normal if they were between 10 pg/ml and 75 pg/ml. We extracted details from the vitamin D prescriptions to determine approximate daily dose and length of
6
treatment. The patients were divided into 3 groups based on the daily vitamin D dose (low dose < 1000 units per day; moderate dose 1000 to 4000 units per day; high dose > 4000 units per day). Details about steroid therapy in the 3 months preceding a hypercalcemia event were also noted. Patients were classified as taking no steroids, low dose steroids(less than or equal to 15 mg equivalent prednisone per day) or high dose steroids(more than 15 mg prednisone per day for more than 2 weeks). Renal failure was defined as serum Creatinine > 1.1 mg/dl in females and > 1.2 mg/dl in males. Primary Outcome The primary outcome was the prevalence of any detected hypercalcemia (symptomatic or asymptomatic) that may or may not have required hospitalization during the first 2 years after initial contact (Group S) or 2 years after the first prescription (Group D). Hypercalcemia was defined as calcium levels greater than 10.2 mg/dl. Mild hypercalcemia was defined as calcium levels between 10.2 mg/dl and 11.9 mg/dl. Calcium levels greater than or equal to 12 were defined as moderate to severe hypercalcemia. Secondary Outcomes A secondary outcome was the proportion of patients that had received vitamin D prescriptions who had adequate blood work performed prior to the prescription.
Data Analysis: We assumed a rate of hypercalcemia of 11%, based on the published literature [9]. In order to detect a 10% difference in hypercalcemic complication rates between the 2 groups we estimated a total sample size of 505, based on a power of 80% and alpha of 0.05.
7
The data were analysed using SPSS software (Version 21). For univariate analysis of categorical data we used chi square test. For univariate analysis of continuous data Students t-test was used. For multivariate analyses, multivariate logistic regression analysis was used.
Results: Demographic features of both groups are listed in Table 1. Both groups were approximately 50% female, predominantly African American and had similar mean age. Approximately 25% of patients in each group were on steroids in the 3 months preceding their highest calcium level. The proportion of patients with renal failure was similar in both groups, as was the median Angiotensin Converting Enzyme (ACE) level. Majority (> 80%) of the patients were seen and followed by primary care providers and did not see a pulmonologist within the hospital system during the 2 years. 25 hydroxy vitamin D (25-OH-vit D) level testing Only 69.9% of the patients prescribed a vitamin D supplement had 25-OH-vit D levels tested prior to the prescription. As expected, levels of testing were significantly lower in Group S (29.1%). (Table 2) 1,25 Dihydroxy vitamin D (1,25-OH-vit D) level testing Only 23% of patients given a vitamin D prescription had 1,25-OH-vit D levels tested prior to the prescription. As expected, the proportion of patients receiving this test was significantly lower in Group S (5.1%). (Table 2)
8
Vitamin D prescription details Sixty percent of the patients received low dose vitamin D supplementation, 16.8% received moderate vitamin D supplementation and 23% received high dose vitamin D supplementation. The mean duration of supplementation was 1.3 years. Forty percent of the patients had the therapy discontinued at some point during the study period. Vitamin D Deficiency Based on 25-OH-vit D levels 47.4%, 13.7% and 10.5% patients in Group D were classified as having vitamin D deficiency, vitamin D insufficiency and normal vitamin D levels respectively. 30% patients had no measurement of 25-OH-vit D. In Group S, 10.8% 11.9% and 6.7% were classified as having vitamin D deficiency, vitamin D insufficiency and normal vitamin D levels respectively. 71% of patients did not have 25-OH-vit D levels tested in this group. Based on 1,25-OH-vit D levels 4.1% patients in Group D were diagnosed as having true vitamin D deficiency. In the same group, 10.2% had normal 1,25-OH-vit D levels, 8.7% had high 1,25OH-vit D levels and 77% had no 1,25-OH-vit D levels tested. In Group S, 95% of the patients did not have 1,25-OH-vit D levels tested. Appropriate Lab work prior to vitamin D prescription Patients who either did not have 1,25-OH-vit D levels measured or had normal or high levels of 1,25-OH-vit D prior to a vitamin D prescription were labeled as not having appropriate lab work prior to prescription. Approximately 87% of patients in Group D did not have appropriate lab work prior to their prescription. This was seen across all prescription strengths of vitamin D (Table 3).
9
Fifty two percent of patients in Group D either did not have a 25-OH-vit D level measured or were given prescriptions despite normal levels of 25-OH-Vit D. This was particularly seen in the group of patients that received low dose vitamin D (75%) and less so in the high dose group (10%).
Hypercalcemia Hypercalcemia occurred more frequently in Group D as compared to Group S (42.3% and 18.3% respectively, p
