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

NCT04939792 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HRP-503
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 25-hydroxy-vitamin D

  Change in blood levels of 25(OH)VD

  6 months

Secondary Outcomes (2)

• TNF-α

  6 months

• HOMA-IR

  6 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

L-Cysteine

EXPERIMENTAL

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

Drug: L-cysteine

Vitamin D3

EXPERIMENTAL

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

Drug: Vitamin D

Vitamin D3 and L-Cysteine

EXPERIMENTAL

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

Drug: Vitamin D + L-cysteine

Interventions

Vitamin D DRUG

Capsules ingested orally

Also known as: cholecalciferol

Vitamin D3

Placebo DRUG

Capsule ingested orally

Also known as: starch

Placebo

Vitamin D + L-cysteine DRUG

Capsule ingested orally

Also known as: combination of vitamin D and L-cysteine

Vitamin D3 and L-Cysteine

L-cysteine DRUG

Capsule ingested orally

Also known as: amino acid

L-Cysteine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

Study Sites (1)

Louisiana State University Health Shreveport

Shreveport, Louisiana, 71103, United States

Location

Related Publications (1)

• 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.

  PMID: 39882299 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Insulin Resistance; Alzheimer Disease

Interventions

Vitamin D; Cholecalciferol; Starch; Cysteine; Amino Acids

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Sulfhydryl Compounds; Amino Acids, Neutral; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 25, 2021
• Study Start: November 6, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 3 years

Locations

US (1)