Efficacy Of Ergocalciferol In Adults According To BMI

Study Overview
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Brief Summary
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Vitamin D insufficiency is an increasing trend in the United States. According to the NHANES data collection there was a near doubling of patients with vitamin D deficiency in 10 years. Vitamin D deficiency is associated with several adverse outcomes such as increased fractures, certain microbial diseases, cardiovascular diseases, and metabolic dysfunction. The increasing prevalence of vitamin D deficiency has been attributed to the increasing prevalence of obesity. Several studies have shown that obese patients have lower 25-OH vitamin D (25-OHD) levels compared to nonobese patients and obese patients require more vitamin D compared to nonobese patients. The most commonly prescribed medication to replete vitamin D deficiency is oral ergocalciferol. To date, no prospective trials have been published to evaluate a standard protocol in the treatment of vitamin D insufficiency in adults.

Official Title
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Efficacy Of Ergocalciferol In Adults According To BMI

Conditions
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Obesity, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Ergocalciferols
* Drug: Ergocalciferols


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study subjects have to be between the ages of 18 to 65 with a serum 25OHD level less than 20 ng/ml. Exclusion Criteria: Participants will be excluded if they have any of the following: Due to the inaccuracies of BMI in patients with increased muscle mass, in group with a BMI 25-35: men with a waist circumference < 90 cm ; women < 80 cm Chronic liver disease defined by any clinical or a history of serum AST or ALT > 2 times ULN Kidney disease defined as a GFR <60 ml/min Sarcoidosis Any known malignancy Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass Primary hyperparathyroidism or hypercalcemia, Patients that are pregnant or considering pregnancy. Patients taking certain medications such as glucocorticoids, anti-seizure medications such has phenobarbital or phenytoin or patients taking antiviral medications for HIV as these are known to cause vitamin D deficiency Individuals excluded from having a DXA scan Study participants will be excluded from having a DXA scan if any of the following: Any amputation of a extremity including toes If they have a pacemaker, automatic defibrillator, coronary stents or metal suture material in the heart If they have artificial joints, pins, plate or any other type of metal objects If they have received contrast material such as barium in the past 7 days If they have had a nuclear medicine study in the past 3 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMI <25<br>Normal BMI | Drug: Ergocalciferols<br>* Treatment 1- 400,000 IU<br>Drug: Ergocalciferols<br>* Treatment 2- 800,000 IU<br>|
| Experimental: BMI 25-35<br>Overweight and obese by BMI | Drug: Ergocalciferols<br>* Treatment 1- 400,000 IU<br>Drug: Ergocalciferols<br>* Treatment 2- 800,000 IU<br>|
| Experimental: BMI >35<br>Obese by BMI | Drug: Ergocalciferols<br>* Treatment 1- 400,000 IU<br>Drug: Ergocalciferols<br>* Treatment 2- 800,000 IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25-hydroxy-vitamin D level |  | 12 weeks |