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OpenTrials
Completed

NCT Number: NCT04939792

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

Capsules ingested orally

Other names: cholecalciferol

Placebo

Drug

Capsule ingested orally

Other names: starch

Vitamin D + L-cysteine

Drug

Capsule ingested orally

Other names: combination of vitamin D and L-cysteine

L-cysteine

Drug

Capsule ingested orally

Other names: amino acid

Primary outcomes

  1. 25-hydroxy-vitamin D

    Time frame: 6 months

    Change in blood levels of 25(OH)VD

Secondary outcomes

  1. TNF-α

    Time frame: 6 months

    Whether any increase in vitamin D beneficially decreases insulin resistance

  2. HOMA-IR

    Time frame: 6 months

    Whether any decrease in TNF-a beneficially decreases insulin resistance

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center Shreveport

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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