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

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ClinicalTrials.gov Identifier: NCT04939792
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : March 8, 2023
Sponsor:
Information provided by (Responsible Party):
Sushil Jain, Louisiana State University Health Sciences Center Shreveport

Study Description
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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.

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimization of Blood Levels of 25(OH)-Vitamin D in African Americans
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Other Name: starch
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
Other Name: amino acid
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
Other Name: cholecalciferol
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
Other Name: combination of vitamin D and L-cysteine


Outcome Measures
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Primary Outcome Measures :
  1. 25-hydroxy-vitamin D [ Time Frame: 6 months ]
    Change in blood levels of 25(OH)VD


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939792


Contacts
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Contact: Sushil K Jain, Ph.D 318-675-6086 sushil.jain@lsuhs.edu
Contact: Alonzo L Zachary 318-675-6086 alz001@lsuhs.edu

Locations
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United States, Louisiana
Louisiana State University Health Shreveport Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Sushil K Jain, PhD    318-675-6086    sushil.jain@lsuhs.edu   
Principal Investigator: Sushil K Jain, PhD         
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
  Study Documents (Full-Text)

Documents provided by Sushil Jain, Louisiana State University Health Sciences Center Shreveport:
Study Protocol  [PDF] November 6, 2020
Informed Consent Form  [PDF] May 7, 2020

More Information
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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: June 25, 2021    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the study
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 3 years

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sushil Jain, Louisiana State University Health Sciences Center Shreveport:
African American;
Vitamin D;
Insulin resistance
Alzheimer's Disease
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
 Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents