Skip to content

Optimization of Blood Levels of 25(OH)-Vitamin D in African Americans

Optimization of Blood Levels of 25(OH)-Vitamin D in African Americans

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04939792
Enrollment
165
Registered
2021-06-25
Start date
2020-11-06
Completion date
2022-10-31
Last updated
2023-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

African American;, Vitamin D;, Insulin resistance, Alzheimer's Disease

Brief summary

Two-thirds of the US population, particularly African Americans (AA), is at risk for inadequate or deficient 25-hydroxy-vitamin D (25(OH)VD). Epidemiological studies demonstrate an association between better health outcomes and higher blood levels of 25(OH)VD . Randomized controlled clinical trials have shown that, while supraphysiological high doses of VD are needed to achieve adequate blood levels of 25(OH)VD, not all subjects respond to them. Recent studies have also questioned the therapeutic effects of high-dose VD supplementation. Severe VD deficiency has been associated independently with the future risk of mild cognitive impairment (MCI) and dementia. A reduction in GSH and an increase in the oxidative stress levels of serum, erythrocytes, and circulating lymphocytes has been observed in MCI and Alzheimer disease, findings similar to those in VD deficient persons. Scholarly reviews conclude that excess oxidative stress is one of the major risk factors for AD and support a potential therapeutic role for L-cysteine (LC, a GSH precursor) and vitamin D (VD) supplementation in the treatment of Alzheimer disease symptoms. This application presents the investigators' design for a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that supplementation with VD in combination with L-cysteine (LC) is more successful at optimizing the statuses of 25(OH)VD \[biological signatures\] and simultaneously decreasing TNF-α, IR \[functional or clinical outcomes\], and oxidative stress, suggesting a better therapeutic approach compared with supplementation with VD alone in AA subjects.

Interventions

DRUGVitamin D

Capsules ingested orally

DRUGPlacebo

Capsule ingested orally

DRUGVitamin D + L-cysteine

Capsule ingested orally

Capsule ingested orally

Sponsors

Louisiana State University Health Sciences Center Shreveport
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* African American volunteers only * Participants between the ages of 18 and 65 * Must be In good general health * Women with negative pregnancy tests

Exclusion criteria

* Subjects with Diabetes, Heart disease, Sickle Cell disease, or Epilepsy * Subjects with serum positive pregnancy test or breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
25-hydroxy-vitamin D6 monthsChange in blood levels of 25(OH)VD

Secondary

MeasureTime frameDescription
TNF-α6 monthsWhether any increase in vitamin D beneficially decreases insulin resistance
HOMA-IR6 monthsWhether any decrease in TNF-a beneficially decreases insulin resistance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026