To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans
Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
Three hundred thirty (330) overweight, pre-hypertensive/controlled hypertensive,
African-American participants will be enrolled in a 8 week study to assess the effect of two
administrations of Vitamin D3 on Vitamin D serum responsiveness as a function of clinical,
biologic and genetic factors. The investigators anticipate that at least 300 participants
will complete this study.
Written, signed and dated informed consent to participate in the study will be given by the
participant or a legally acceptable representative, in accordance with the International
Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable
regulations, before completing any study-related activities/procedures. The original signed
and dated consent will be kept in the subject's research file and a copy given to the
subject. A copy will also be placed in their medical record.
Phase:
N/A
Details
Lead Sponsor:
Charles Drew University of Medicine and Science
Collaborators:
Morehouse School of Medicine National Institute on Minority Health and Health Disparities (NIMHD)
Treatments:
Calcifediol Cholecalciferol Ergocalciferols Hydroxycholecalciferols Vitamin D Vitamins