Rationale and design of a placebo controlled randomized trial to assess short term, high-dose oral cholecalciferol on select laboratory and genomic responses in African Americans with hypovitaminosis D.

Abstract

Cardiovascular Disease (CVD) and related disorders remain a leading cause of health disparities and premature death for African Americans. Hypovitaminosis D is disproportionately prevalent in African Americans and has been linked to CVD and CVD risk factors including hypertension, diabetes and obesity. Thus, hypovitaminosis D may represent a common pathway influencing CV risk factors in a select subgroup of persons. The purpose of this paper is to report the study design of a prospective eight week prospective double-blind randomized, placebo-controlled trial (n = 330 allocated 2:1 to intervention vs. control) to assess the effect of placebo vs. high-dose oral cholecalciferol (100,000 IU vitamin D3 at baseline and week 2) on 6-week change of select biologic cardiometabolic risk factors (including parathyroid hormone to assess biologic activity, pro-inflammatory/pro-thrombotic/fibrotic markers, insulin sensitivity and vitamin D metabolites) and their relationship to vitamin D administration and modification by vitamin D receptor polymorphisms in overweight, hypertensive African Americans with hypovitaminosis D. Findings from this trial will present insights into potential causal links between vitamin D repletion and mechanistic pathways of CV disease, including established and novel genomic markers.

• Authors: Keith C Norris, M Edwina Barnett, Yuan-Xiang Meng, David Martins, Susanne B Nicholas, Gary H Gibbons, Jae Eun Lee
• Journal: Contemporary clinical trials (Contemp Clin Trials) Vol. 72 Pg. 20-25 (09 2018) ISSN: 1559-2030 [Electronic] United States
• PMID: 30012355 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2018 Elsevier Inc. All rights reserved.

Chemical References

• Cytokines
• Parathyroid Hormone
• Vitamin D-Binding Protein
• Vitamins
• Cholecalciferol

Topics

• Black or African American
• Cholecalciferol (administration & dosage)
• Cytokines (metabolism)
• Double-Blind Method
• Humans
• Hypertension (complications, metabolism, physiopathology)
• Inflammation
• Insulin Resistance
• Overweight (complications, metabolism)
• Parathyroid Hormone (metabolism)
• Vitamin D Deficiency (complications, drug therapy)
• Vitamin D-Binding Protein (genetics)
• Vitamins (administration & dosage)
• Randomized Controlled Trials as Topic