Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function
Status:
Completed
Trial end date:
2019-12-07
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the effects of two different forms of vitamin D
supplements (vitamin D3 and 25-hyrdroxyvitamin D3 [25(OH)D3]) on vitamin D levels in the
blood, and on markers of skeletal and immune health. This study is designed as a pilot study.
A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12
Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a
screening visit during which a medical history will be taken, a physical exam performed, a
dietary questionnaire administered, and blood collected. The purpose of the screening visit
is to identify vitamin D-deficient (25-hydroxyvitamin D <20 ng/ml) individuals who are
candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to
receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After
initiating supplementation, study patients will return for follow-up visits at weeks 4, 8,
and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as
well as markers of skeletal and immune function. Participation in this study will therefore
involve a total of 5 visits (1 screening visit, 1 randomization visit during which
participants will receive their study supplements, 3 follow-up visits). After all data is
collected, changes in vitamin D levels in the blood following supplementation with either
vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance
and immune function. Knowledge gained from this study may have a significant impact on how
vitamin D status is defined, and how vitamin D repletion is administered.
Phase:
Early Phase 1
Details
Lead Sponsor:
University of California, Los Angeles
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Treatments:
Calcifediol Cholecalciferol Ergocalciferols Hydroxycholecalciferols Vitamin D Vitamins