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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04939792
• Other study ID #: HRP-503
• Status: Completed
• Phase: Early Phase 1
• Start date: November 6, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: June 2023
• Source: Louisiana State University Health Sciences Center Shreveport
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
Capsules ingested orally
• Placebo
Capsule ingested orally
• Vitamin D + L-cysteine
Capsule ingested orally
• L-cysteine
Capsule ingested orally

Locations

Country	Name	City	State
United States	Louisiana State University Health Shreveport	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center Shreveport

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25-hydroxy-vitamin D	Change in blood levels of 25(OH)VD	6 months
Secondary	TNF-a	Whether any increase in vitamin D beneficially decreases insulin resistance	6 months
Secondary	HOMA-IR	Whether any decrease in TNF-a beneficially decreases insulin resistance	6 months