N/A
Completed N=330
To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans
Hypovitaminosis D
Source: ClinicalTrials.gov NCT02802449 ↗
Enrolled (actual)
330
Serious AEs
0.3%
Results posted
May 2018
Primary outcomePrimary: Plasma PTH Level — 58.29; 60.73; 57.88; 54.05 pg/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma PTH Level |
58.29; 60.73; 57.88; 54.05 | — |
| PRIMARY Vitamin D3 Level |
17.02; 16.55; 16.64; 32.73 | — |
| SECONDARY Oxidative Stress Markers: Cysteine |
253.5; 252.4; 249.0; 241.2 | — |
| SECONDARY Oxidative Stress Markers: Homocysteine |
11.5; 11.9; 11.0; 11.8 | — |
| SECONDARY Oxidative Stress Markers: GSH |
4.1; 4.1; 3.6; 3.5 | — |
| SECONDARY Oxidative Stress Markers: Isoprostane |
8298.6; 11914.9; 687.1; 9979.7 | — |
Eligibility 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 5 and 30 ng/ml)
- Body mass index (BMI) > 25 kg/m2 and 8.5%)
- Screening Vitamin D (D2 and D3 level) 25 ng/ml (recommended normal level is > 30 ng/ml)
- Estimated glomerular filtration rate (eGFR) 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 ( 45 kg/m2
Data sourced from ClinicalTrials.gov (NCT02802449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.