Efficacy Of Ergocalciferol In Adults According To BMI
| Status: | Terminated |
|---|---|
| Conditions: | Obesity Weight Loss, Other Indications, Gastrointestinal |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/12/2017 |
| Start Date: | July 2011 |
| End Date: | April 2017 |
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.
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.
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:
1. 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
2. Chronic liver disease defined by any clinical or a history of serum AST or ALT >
2 times ULN
3. Kidney disease defined as a GFR <60 ml/min
4. Sarcoidosis
5. Any known malignancy
6. Known malabsorption disorder to include inflammatory bowel disease, celiac
disease, cystic fibrosis, history of gastric bypass
7. Primary hyperparathyroidism or hypercalcemia,
8. Patients that are pregnant or considering pregnancy.
9. 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
10. Individuals excluded from having a DXA scan
Study participants will be excluded from having a DXA scan if any of the following:
1. Any amputation of a extremity including toes
2. If they have a pacemaker, automatic defibrillator, coronary stents or metal suture
material in the heart
3. If they have artificial joints, pins, plate or any other type of metal objects
4. If they have received contrast material such as barium in the past 7 days
5. If they have had a nuclear medicine study in the past 3 days
We found this trial at
1
site
8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Alicia L Warnock, MD
Phone: 301-295-5182
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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