At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Eight Week Double Blinded Randomized, Placebo-controlled Trial to Assess the Effect of Two Doses of 100,000 IU Vitamin D3 by Mouth on Select Genetic Responses in Overweight, Hypertensive African-Americans With Hypovitaminosis D
In Brief
A clinical study evaluating 25 Hydroxy- Vitamin D3 [25 (OH) D3] and Placebo for Hypovitaminosis D. Completed, enrolled 330 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Two 50,000 IU tablets of oral Vitamin D3 \[also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3\] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator.