Efficacy Of Ergocalciferol In Adults According To BMI
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- serum 25-hydroxy-vitamin D level
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
BMI <25
Normal BMI
Intervention: Ergocalciferols (Drug)
BMI 25-35
Overweight and obese by BMI
Intervention: Ergocalciferols (Drug)
BMI >35
Obese by BMI
Intervention: Ergocalciferols (Drug)
Outcomes
Primary Outcomes
serum 25-hydroxy-vitamin D level
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported