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To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans

NCT02802449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2019-02-15

Study results available
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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.

Conditions

  • Hypovitaminosis D

Interventions

DRUG

25 Hydroxy- Vitamin D3 [25 (OH) D3]

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.

DRUG

Placebo

Sponsors & Collaborators

  • Morehouse School of Medicine

    collaborator OTHER

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • Charles Drew University of Medicine and Science

    lead OTHER

Principal Investigators

  • David Martins, MD · Charles Drew University of Medicine and Science

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-03-31
Completion
2018-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02802449 on ClinicalTrials.gov