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

NCT ID: NCT04939792

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-06
• Study Completion Date: 2022-10-31

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Initially, all of the study subjects will be provided placebo supplementation as a placebo run-in period for one month before randomization. The placebo run-in period is meant to stabilize subjects in the study and will prevent any effect due solely to inclusion in the study. Placebo and supplement capsules will be similar in appearance, taste, texture, and smell, and will be provided by the pharmacist, who will have the codes for which subjects are assigned to which supplement or placebo.

During testing, the placebo group will take two placebo capsules a day in the morning. Supplements will be taken daily with food at breakfast for 6 months, while participants continue to carry on a normal lifestyle

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsule ingested orally

L-Cysteine

LC group will receive two capsules of LC daily. Supplements will be taken daily with food at breakfast for 6 months, while participants continue to carry on a normal lifestyle

Group Type: EXPERIMENTAL

L-cysteine

Intervention Type: DRUG

Capsule ingested orally

Vitamin D3

VD group will take two capsules and each capsule will contain 1000 IU VD daily. Supplements will be taken daily with food at breakfast for 6 months, while participants continue to carry on a normal lifestyle

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Capsules ingested orally

Vitamin D3 and L-Cysteine

VD+LC group will take daily two capsule containing 1000 IU+500 mg LC. Supplements will be taken daily with food at breakfast for 6 months, while participants continue to carry on a normal lifestyle

Group Type: EXPERIMENTAL

Vitamin D + L-cysteine

Intervention Type: DRUG

Capsule ingested orally

Interventions

Vitamin D

Capsules ingested orally

Intervention Type: DRUG

Placebo

Capsule ingested orally

Intervention Type: DRUG

Vitamin D + L-cysteine

Capsule ingested orally

Intervention Type: DRUG

L-cysteine

Capsule ingested orally

Intervention Type: DRUG

Other Intervention Names

cholecalciferol; starch; combination of vitamin D and L-cysteine; amino acid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Louisiana State University Health Sciences Center Shreveport

OTHER

Sponsor Role: lead

Responsible Party

Sushil Jain

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Louisiana State University Health Shreveport

Shreveport, Louisiana, United States

Countries

United States

References

Jain SK, Justin Margret J, Zachary A Jr, Lally MM, Vanchiere JA, Mhanna MJ, Shi R, Levine SN. Effects of vitamin D and L-cysteine cosupplementation on circulating bioavailable and total 25-hydroxy-vitamin D, the free/total testosterone ratio and inflammatory biomarkers in healthy vitamin D-deficient African Americans: a placebo-controlled double-blind clinical trial. BMJ Nutr Prev Health. 2024 Aug 7;7(2):e000856. doi: 10.1136/bmjnph-2023-000856. eCollection 2024.

Reference Type: DERIVED

PMID: 39882299 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HRP-503

Identifier Type: -

Identifier Source: org_study_id