Status:
COMPLETED
Optimizing Vitamin D Nutrition in Healthy Adults
Lead Sponsor:
Winthrop University Hospital
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 o...
Detailed Description
There is ample evidence that improvement in vitamin D nutrition retards bone loss and prevents fractures in the elderly. It is clear that many people living in areas of northern latitude have less tha...
Eligibility Criteria
Inclusion
- Healthy African-American and Caucasian adults aged 18-65 years.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00327847
Start Date
December 1 2004
End Date
December 1 2006
Last Update
September 25 2008
Active Locations (1)
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1
Winthrop University Hospital
Mineola, New York, United States, 11501