To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans
To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans
NCT ID: NCT02802449 Phase: NA Status: COMPLETED Enrollment: 330 Completion: 2018-07
Conditions
Hypovitaminosis D
Interventions
25 Hydroxy- Vitamin D3 [25 (OH) D3], Placebo
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.
Primary Outcome
Plasma PTH Level