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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Capsules ingested orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 25-hydroxy-vitamin D | Change in blood levels of 25(OH)VD | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| TNF-α | Whether any increase in vitamin D beneficially decreases insulin resistance | 6 months |
| HOMA-IR | Whether any decrease in TNF-a beneficially decreases insulin resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University Health Shreveport | Shreveport | Louisiana | 71103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39882299 | Derived | 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. |
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After completion of the study
3 years
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 8, 2024 | |
| Reset | Jul 30, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2020 | Jun 8, 2021 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2020 | Jun 8, 2021 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 8, 2024 | Jul 30, 2024 |
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D007333 | Insulin Resistance |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| D013213 | Starch |
| D003545 | Cysteine |
| D000596 | Amino Acids |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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|
| Placebo | Drug | Capsule ingested orally |
|
|
| Vitamin D + L-cysteine | Drug | Capsule ingested orally |
|
|
| L-cysteine | Drug | Capsule ingested orally |
|
|
| 6 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013438 | Sulfhydryl Compounds |
| D021542 | Amino Acids, Neutral |
| D000602 | Amino Acids, Peptides, and Proteins |