To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans
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|ClinicalTrials.gov Identifier: NCT02802449|
Recruitment Status : Completed
First Posted : June 16, 2016
Results First Posted : May 24, 2018
Last Update Posted : February 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypovitaminosis D||Drug: 25 Hydroxy- Vitamin D3 [25 (OH) D3] Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||July 2018|
Placebo Comparator: Placebo
The participant will be randomized to receive two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Active Comparator: 25 hydroxy-Vitamin D3 or [25 (OH) D3]
The participant will be randomized to receive two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.
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.
Other Name: Vitamin D3
- Plasma PTH Level [ Time Frame: Baseline and Week 6 ]Building upon our hypothesis above, this aim exploits the fact that the nuclear Vit-D Receptor (VDR) regulates parathyroid hormone (PTH) gene transcription. Therefore the plasma PTH level serves as a sensitive biomarker of the Vit-D nutri-genomic response. This aim will define the multivariate determinants (covariates such as age, BMI, baseline Vit-D level and dietary calcium) of the Vit-D-PTH level relationship (the primary outcome variable) in African-Americans. It is anticipated that the Vit-D supplementation trial will document a wide variance of Vit-D-PTH level relationships that will identify patients at the upper and lower quartiles of the distribution that are either 'nutrient-responsive' or 'nutrient-resistant'. These studies should help identify the 'clinical' characteristics of the sub-set of African-Americans that exhibit the poorest response to Vit-D supplementation.
- Vitamin D3 Level [ Time Frame: Baseline and Week 6 ]
- Oxidative Stress Markers: Cysteine [ Time Frame: Baseline and Week 6 ]
- Oxidative Stress Markers: Homocysteine [ Time Frame: Baseline and Week 6 ]
- Oxidative Stress Markers: GSH [ Time Frame: Baseline and Week 6 ]
- Oxidative Stress Markers: Isoprostane [ Time Frame: Baseline and Week 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802449
|United States, California|
|Charles Drew University|
|Los Angeles, California, United States, 90059|
|Principal Investigator:||David Martins, MD||Charles Drew University of Medicine and Science|