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Study aim
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Comparison of the effects of vitamin D and N-acetylcysteine supplementation on the expression of cellular senescence genes and inflammatory factors in the elderly with vitamin D deficiency.
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Design
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The clinical trial has 4 intervention groups, with parallel, double-blind, randomized groups, with a sample size of 100 elderly people with vitamin D deficiency. Random allocation will be done in the form of Stratified Randomization.
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Settings and conduct
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Elderly people with vitamin D deficiency will be classified into one of the four study groups. Before and after the intervention, blood samples will be taken from them and biochemical, molecular and staining tests will be done on the sample.
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Participants/Inclusion and exclusion criteria
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Elderly people with a body mass index of 25-32 kg/m2; Serum vitamin D deficiency (less than 30 ng/mL); Age over 65 years old; Absence of chronic and acute inflammatory and infectious diseases; No diabetes and thyroid diseases; Absence of Alzheimer's and dementia; No alcohol and smoking; Lack of medication or a disorder that affects vitamin D metabolism (anticonvulsant drugs, antituberculosis drugs, glucocorticoids, HIV drugs). Not receiving vitamin D, NAC and antioxidant supplements in the last three months; Non-participation in other clinical trial studies at the same time as the present study. Exclusion critria: Hypercalcemia (more than 2.6 mmol/L), dysparathyroidism, kidney failure and stones, and long-term treatment with bisphosphonates and corticosteroids. Consumption of less than 90% of prescribed supplements
Unwillingness to cooperate during the intervention.
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Intervention groups
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Group 1. NAC 600 mg/d + 1000 IU/d vitamin D
Group 2. 5000 IU/d vitamin D
Group 3. NAC 600 mg/d + 5000 IU/d vitamin D
Group 4. 1000 IU/d vitamin D.
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Main outcome variables
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Gene expression of p21, p16, IL-6, β-galactosidase activity, serum IL-6, CRP and TNFα