Trial · NCT02802449

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

NCT02802449, Not applicable, Completed, Charles Drew University of Medicine and Science; results first posted 2018-05-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans. Trials, record NCT02802449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02802449

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans
NCT number: NCT02802449
Status: Completed
Phases: Not applicable
Enrollment: 330 participants, actual
Lead sponsor: Charles Drew University of Medicine and Science
Conditions: Hypovitaminosis D
Interventions: 25 Hydroxy- Vitamin D3 [25 (OH) D3], Placebo
First posted: 2016-06-16
Last updated: 2019-02-15
Results first posted: 2018-05-24

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Plasma PTH Level	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.
Primary	Vitamin D3 Level	Baseline and Week 6
Secondary	Oxidative Stress Markers: Cysteine	Baseline and Week 6
Secondary	Oxidative Stress Markers: Homocysteine	Baseline and Week 6
Secondary	Oxidative Stress Markers: GSH	Baseline and Week 6
Secondary	Oxidative Stress Markers: Isoprostane	Baseline and Week 6

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Plasma PTH Level	Baseline and Week 6	pg/ml	MEAN
PRIMARY	Vitamin D3 Level	Baseline and Week 6	ng/ml	MEAN
SECONDARY	Oxidative Stress Markers: Cysteine	Baseline and Week 6	umol/L	MEAN
SECONDARY	Oxidative Stress Markers: Homocysteine	Baseline and Week 6	umol/L	MEAN
SECONDARY	Oxidative Stress Markers: GSH	Baseline and Week 6	umol/L	MEAN
SECONDARY	Oxidative Stress Markers: Isoprostane	Baseline and Week 6	pg/ml	MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Plasma PTH Level	Placebo	Baseline	58.29	Standard Deviation 23.82	pg/ml
Plasma PTH Level	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	Baseline	60.73	Standard Deviation 26.04	pg/ml
Plasma PTH Level	Placebo	Week 6	57.88	Standard Deviation 22.23	pg/ml
Plasma PTH Level	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	Week 6	54.05	Standard Deviation 26.12	pg/ml
Vitamin D3 Level	Placebo	Baseline	17.02	Standard Deviation 4.51	ng/ml
Vitamin D3 Level	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	Baseline	16.55	Standard Deviation 4.87	ng/ml
Vitamin D3 Level	Placebo	Week 6	16.64	Standard Deviation 4.90	ng/ml
Vitamin D3 Level	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	Week 6	32.73	Standard Deviation 7.14	ng/ml
Oxidative Stress Markers: Cysteine	Placebo	Cysteine (Baseline)	253.5	Standard Deviation 41.5	umol/L
Oxidative Stress Markers: Cysteine	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	Cysteine (Baseline)	252.4	Standard Deviation 35.6	umol/L

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	111
Overall Study	STARTED	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	219
Overall Study	COMPLETED	Placebo	102
Overall Study	COMPLETED	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	202
Overall Study	NOT COMPLETED	Placebo	9
Overall Study	NOT COMPLETED	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	17

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Elevated Blood Pressure	Cardiac disorders	Placebo	1	111	2
other	Elevated Blood Pressure	Cardiac disorders	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	4	219	5
other	Abnormal Lab Value	Renal and urinary disorders	Placebo	0	111	0
other	Abnormal Lab Value	Renal and urinary disorders	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	1	219	1
other	Fractured Right Arm	Musculoskeletal and connective tissue disorders	Placebo	0	111	0
other	Fractured Right Arm	Musculoskeletal and connective tissue disorders	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	1	219	1
other	Bronchitis	Respiratory, thoracic and mediastinal disorders	Placebo	0	111	0
other	Bronchitis	Respiratory, thoracic and mediastinal disorders	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	1	219	1
other	Neck Strain	Musculoskeletal and connective tissue disorders	Placebo	0	111	0
other	Neck Strain	Musculoskeletal and connective tissue disorders	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	1	219	1

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	111
Total, all-cause mortality	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	0	219
Total, other adverse events	Placebo	5	111
Total, other adverse events	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	15	219
Total, serious adverse events	Placebo	1	111
Total, serious adverse events	25 Hydroxy-Vitamin D3 or [25 (OH) D3]	0	219

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U54MD008149	RCMI Translational Research Network (RTRN)	OFILI, ELIZABETH O.	MOREHOUSE SCHOOL OF MEDICINE	NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES	2012 to 2018

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
25 Hydroxy-Vitamin D3 or [25 (OH) D3] vs Placebo: deaths from any cause	Trial comparisons
25 Hydroxy-Vitamin D3 or [25 (OH) D3] vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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