Optimization of Blood 25-hydroxy-vitamin D Levels in African Americans

Sponsor

Louisiana State University Health Sciences Center Shreveport (Other)

Overall Status

Recruiting

CT.gov ID

NCT04939792

Collaborator

(none)

120

Enrollment

Location

Arms

22.8

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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. 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 and IR [functional or clinical outcomes], suggesting a better therapeutic approach compared with supplementation with VD alone in AA subjects.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency	Drug: Vitamin D Drug: Placebo Drug: Vitamin D + L-cysteine Drug: L-cysteine	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 6, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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	Drug: Placebo Capsule ingested orally
Experimental: 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	Drug: L-cysteine Capsule ingested orally
Experimental: 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	Drug: Vitamin D Capsules ingested orally
Experimental: 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	Drug: Vitamin D + L-cysteine Capsule ingested orally

Outcome Measures

Primary Outcome Measures

25-hydroxy-vitamin D [6 months]
Change in blood levels of 25(OH)VD

Secondary Outcome Measures

TNF-α [6 months]
Whether any increase in vitamin D beneficially decreases insulin resistance
HOMA-IR [6 months]
Whether any decrease in TNF-a beneficially decreases insulin resistance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Louisiana State University Health Shreveport	Shreveport	Louisiana	United States	71103

Sponsors and Collaborators

Louisiana State University Health Sciences Center Shreveport

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Sushil Jain, Principle Investigator, Louisiana State University Health Sciences Center Shreveport

ClinicalTrials.gov Identifier:

NCT04939792

Other Study ID Numbers:

HRP-503

First Posted:

Jun 25, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sushil Jain, Principle Investigator, Louisiana State University Health Sciences Center Shreveport

African American;

Vitamin D;

Insulin resistance

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022