Optimization of Blood 25-hydroxy-vitamin D Levels in African Americans
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Two-thirds of the US population, particularly African Americans (AA), is at risk for
inadequate or deficient 25-hydroxy-vitamin D (25(OH)VD). Epidemiological studies demonstrate
an association between better health outcomes and higher blood levels of 25(OH)VD .
Randomized controlled clinical trials have shown that, while supraphysiological high doses of
VD are needed to achieve adequate blood levels of 25(OH)VD, not all subjects respond to them.
Recent studies have also questioned the therapeutic effects of high-dose VD supplementation.
This application presents the investigators' design for a randomized, double-blind,
placebo-controlled clinical trial to test the hypothesis that supplementation with VD in
combination with L-cysteine (LC) is more successful at optimizing the statuses of 25(OH)VD
[biological signatures] and simultaneously decreasing TNF-α and IR [functional or clinical
outcomes], suggesting a better therapeutic approach compared with supplementation with VD
alone in AA subjects.
Phase:
Early Phase 1
Details
Lead Sponsor:
Louisiana State University Health Sciences Center Shreveport