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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02802449
Recruitment Status : Completed
First Posted : June 16, 2016
Results First Posted : May 24, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Morehouse School of Medicine
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
David Martins, Charles Drew University of Medicine and Science

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.


Condition or disease Intervention/treatment Phase
Hypovitaminosis D Drug: 25 Hydroxy- Vitamin D3 [25 (OH) D3] Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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.
Drug: Placebo
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




Primary Outcome Measures :
  1. 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.

  2. Vitamin D3 Level [ Time Frame: Baseline and Week 6 ]

Secondary Outcome Measures :
  1. Oxidative Stress Markers: Cysteine [ Time Frame: Baseline and Week 6 ]
  2. Oxidative Stress Markers: Homocysteine [ Time Frame: Baseline and Week 6 ]
  3. Oxidative Stress Markers: GSH [ Time Frame: Baseline and Week 6 ]
  4. Oxidative Stress Markers: Isoprostane [ Time Frame: Baseline and Week 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
    • Allergy/intolerance: known allergy to oral vitamin D or microcrystalline cellulose
    • Any female of child-bearing potential who declines to use some method of birth control during the study period

Other:

  • Concurrent participation in other clinical trials or taking experimental medications or within 30 days of completing another trial or study.
  • Patients who are unable to give informed consent
  • Patients who, in the opinion of the Investigator, have a condition which would interfere with their evaluation (e.g. severe mental health disorder)
  • Patients who, in the opinion of the Investigator, may experience an unacceptable health risk by participating in this study
  • Patients who are pregnant or lactating
  • Not African- American or Black by self-identification
  • Body mass index (BMI) > 45 kg/m2

Information from the National Library of Medicine

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


Locations
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United States, California
Charles Drew University
Los Angeles, California, United States, 90059
Sponsors and Collaborators
Charles Drew University of Medicine and Science
Morehouse School of Medicine
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: David Martins, MD Charles Drew University of Medicine and Science
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Responsible Party: David Martins, Professor of Medicine, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT02802449    
Other Study ID Numbers: 11-08-2333
7U54MD008149 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2016    Key Record Dates
Results First Posted: May 24, 2018
Last Update Posted: February 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Martins, Charles Drew University of Medicine and Science:
Vitamin D
Hypovitaminosis D
HTN
Additional relevant MeSH terms:
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Rickets
Avitaminosis
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Calcifediol
Hydroxycholecalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents