Optimizing Vitamin D Nutrition in Healthy Adults
Completed · Not applicable
Conditions studied: Vitamin D Deficiency
In brief
The purpose of this study is to determine the average dosage of oral vitamin D supplementation to maintain optimal vitamin D levels in the body and to see if there are differences in the response to oral vitamin D supplementation between African-American and Caucasian subjects.
Key facts
- Study ID
- NCT00327847
- Run by
- Winthrop University Hospital
- People needed
- 150
- Starts
- 2004-12-01
- Expected to finish
- 2006-12-01
- Last updated by the study team
- 2008-09-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy African-American and Caucasian adults aged 18-65 years.
You may not qualify if…
- Subjects who are not either African-American or Caucasian. The investigators plan to examine racial differences in response to oral vitamin D dosing and, therefore, have chosen the most affected (African-American) and the least affected (Caucasian) racial groups. Including other racial/ethnic groups may confound the results unless they are studied as separate groups.
- Any chronic medical illness including diabetes mellitus, history of myocardial infarction or heart failure, malignancy, hypertension (systolic blood pressure [SBP] > 140), obesity (body mass index [BMI] > 35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination.
- Subjects with osteoporosis or taking medications for osteoporosis such as bisphosphonates.
- Pregnancy.
- Use of medication that influences bone metabolism (i.e. anticonvulsant medications, steroids, diuretics).
- Significant deviation from normal in either history, physical examination, or laboratory tests, as evaluated by the primary investigator.
- Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis.
- Participation in another investigational trial in the past 30 days prior to the screening evaluation.
- Unexplained weight loss of > 15% during the previous year or history of anorexia nervosa.
- Medications that interfere with vitamin D metabolism. Oral contraceptive use will be allowed, but will be appropriately documented.
- Smokers greater than 1 pack per day.
- Patients reporting alcohol intake greater than 2 drinks daily.
- Subjects with baseline 25-OHD level greater than 80 nmol/L or less than 20 nmol/L.
Where it is running
- Winthrop University Hospital — Mineola, New York, United States
Full record on ClinicalTrials.gov
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