Optimizing Vitamin D Nutrition in Healthy Adults

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Winthrop University Hospital
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Healthy African-American and Caucasian adults aged 18-65 years.

Exclusion Criteria:

• 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.