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

NCT02802449 | Completed Results DMC

• 2 other identifiers: 11-08-23337U54MD008149
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vitamin D; Hypovitaminosis D; HTN

Outcome Measures

Primary Outcomes (2)

• Plasma PTH Level

  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.

  Baseline and Week 6

• Vitamin D3 Level

  Baseline and Week 6

Secondary Outcomes (4)

• Oxidative Stress Markers: Cysteine

  Baseline and Week 6

• Oxidative Stress Markers: Homocysteine

  Baseline and Week 6

• Oxidative Stress Markers: GSH

  Baseline and Week 6

• Oxidative Stress Markers: Isoprostane

  Baseline and Week 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

25 hydroxy-Vitamin D3 or [25 (OH) D3]

ACTIVE COMPARATOR

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]

Interventions

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

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.

Also known as: Vitamin D3

25 hydroxy-Vitamin D3 or [25 (OH) D3]

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, 18-70 years of age and self-identified as African-American or Black
• Pre-hypertension or hypertension (well controlled - see below)
• If a potential study patient is not on treatment their SBP must be \> 120 mmHg, or DBP \> 80 mmHg
• Whether on treatment or not SBP must be \<160 mmHg and DBP must be \< 100 mmHg (BP is not an outcome. Controlled BP is for participant safety)
• Screening Vitamin D (D2 and D3 level) \>5 and \< 25 ng/ml (recommended normal level is \> 30 ng/ml)
• Body mass index (BMI) \> 25 kg/m2 and \< 45 kg/m2
• Any female of non-childbearing potential, including any female who:
• has had a hysterectomy,
• has had a bilateral oophorectomy,
• has had a bilateral tubal ligation or
• is postmenopausal (demonstration of total cessation of menses for ≥ 1 year prior to the date of the screening visit)
• Any female of child-bearing potential must agree to use at least one form of contraception (may be a barrier method), during the full duration of the study.

You may not qualify if:

• Concurrent Disease:
• Poorly controlled high blood pressure (SBP ≥160 mmHg or DBP ≥ 100 mmHg)
• Poorly controlled diabetes (HbA1c \>8.5%)
• Screening Vitamin D (D2 and D3 level) \< 5 or \> 25 ng/ml (recommended normal level is \> 30 ng/ml)
• Estimated glomerular filtration rate (eGFR) \< 45 ml/min
• Evidence of disease that could result in hypercalcemia
• History of kidney stones (less than one year prior to screening)
• History of drug, alcohol, or illicit substance abuse (within the past 6 months)
• History of another chronic disease which the investigator feels should preclude the subject from entering the study (e.g. cancer, immunologic disorder)
• Liver function tests (LFTs) greater than twice the upper limit of normal
• Subjects requiring chronic use of nonsteroidal anti-inflammatory drugs or aspirin \>325 mg/day
• Subjects requiring treatment with other vitamin D preparations containing more than 400 IU of vitamin D
• Subjects requiring chronic use of immunosuppressive therapy or corticosteroids
• Recent (\<6 months) myocardial infarction, stroke, or hospitalization for congestive heart failure
• Subjects with clinically apparent hypothyroidism or thyrotoxicosis

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• Morehouse School of Medicine: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Charles Drew University

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

hydroxide ion; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. David Martins
• Organization: Charles Drew University of Medicine and Science

davidmartins@cdrewu.edu

323-568-3353

Study Officials

• David Martins, MD

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: June 16, 2016
• Study Start: September 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2018
• Last Updated: February 15, 2019
• Results First Posted: May 24, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)