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

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Charles Drew University of Medicine and Science
• Collaborators: Morehouse School of Medicine; National Institute on Minority Health and Health Disparities (NIMHD)
• Treatments: Calcifediol; Cholecalciferol; Ergocalciferols; Hydroxycholecalciferols; Vitamin D; Vitamins

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