Louisiana State University Health Shreveport
Shreveport, Louisiana, 71103, United States
NCT Number: NCT04939792
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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Notify Me18 year–65 year
All sexes
Interventional
Early Phase 1
Shreveport, Louisiana, 71103, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Capsules ingested orally
Other names: cholecalciferol
Capsule ingested orally
Other names: starch
Capsule ingested orally
Other names: combination of vitamin D and L-cysteine
Capsule ingested orally
Other names: amino acid
Time frame: 6 months
Change in blood levels of 25(OH)VD
Time frame: 6 months
Whether any increase in vitamin D beneficially decreases insulin resistance
Time frame: 6 months
Whether any decrease in TNF-a beneficially decreases insulin resistance
Louisiana State University Health Sciences Center Shreveport
Other
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