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IRCT20230508058120N1 IRCT 2023-08-20 Shahid Beheshti University of Medical Sciences 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. 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. A double-blind randomized clinical trial 2023-09-23 anticipated 100 Complete https://irct.ir/trial/71231 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who meet the inclusion criteria are placed in one of the four study groups using Starified Blocked Randomization (blocks of 4) based on gender and serum vitamin D level (less than 10 ng, 10-20 and 20-30). Since the amount of vitamin D and the gender of people can have a significant impact on the results of the study, to ensure the same distribution of these variables in the groups, random allocation in the form of stratified randomization and using the random block method (permuted block randomization) with quadruple and double blocks will be used. According to the sample size of 100 that has been determined. The block of four and the block of two will be produced using the online site (www.sealedenvelope.com). To apply concealment in the randomization process, unique codes will be used on medicine cans, the software will generate the desired code. As each person enters the study based on the generated sequence, the medicine package in which the desired code is recorded will be allocated to the person. Therefore, before choosing the person, no one will be aware of the type of treatment he will receive. Also, The random sequence generated during the study will be unpredictable, Blinding description: The study is double-blind. Due to the double-blindness of the study, before the start of the study, the sets of cans containing capsules will be prepared by someone other than the researcher. Also, vitamin D and N-acetyl cysteine capsules will be similar in appearance so the researcher does not know the type of capsules each group receives. In addition, the researcher will be unaware of the allocation of the participants in each of the groups until after the end of the intervention period. N/A Vitamin D deficiency. Intervention 1: First intervention group: 600 mg of N-acetyl cysteine +1000 units of vitamin D ​​daily for 8 weeks. Intervention 2: Second intervention group: 5000 units of vitamin D daily for 8 weeks. Intervention 3: Third intervention group: 600 mg of N-acetyl cysteine +5000 units of vitamin D ​​daily for 8 weeks. Intervention 4: Control group: 1000 units of vitamin D daily for 8 weeks. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: Access starts immediately after the publication of the results To whom: All academic researchers Conditions: The data will be made available to other researchers upon reasonable request Where to obtain: If the results and the article are published, send an email to the corresponding author. How to obtain: If the results and the article are published, send an email to the corresponding author. Comments:
public Samira Rastgoo
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2293 0824 samiraa.rastgoo@gmail.com Shahid Beheshti University of Medical Sciences scientific Samira Rastgoo
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2293 0824 samiraa.rastgoo@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 No chronic and acute inflammatory and infectious diseases Not suffering from diabetes and thyroid diseases Not suffering from Alzheimer's and dementia Not receiving alcohol and smoking Not receiving medication or a disorder that affects vitamin D metabolism (anticonvulsant drugs, antituberculosis drugs, glucocorticoids, HIV drugs) Not receiving vitamin D and N-acetyl cysteine and antioxidant supplements in the last three months Non-participation in other clinical trial studies at the same time as the present study 65 years no limit Both 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 Treatment - Other Treatment - Other Treatment - Other Treatment - Other First intervention group: 600 mg of N-acetyl cysteine +1000 units of vitamin D ​​daily for 8 weeks. Second intervention group: 5000 units of vitamin D daily for 8 weeks Third intervention group: 600 mg of N-acetyl cysteine +5000 units of vitamin D ​​daily for 8 weeks. Control group: 1000 units of vitamin D daily for 8 weeks Changes in p21 gene expression. Timepoint: Before and after intervention. Method of measurement: Quantitative Real-time Polymerase chain reaction. Changes in p16 gene expression. Timepoint: Before and after intervention. Method of measurement: Quantitative Real-time Polymerase chain reaction. Changes in TNFα gene expression. Timepoint: Before and after intervention. Method of measurement: Quantitative Real-time Polymerase chain reaction. Changes in IL-6 gene expression. Timepoint: Before and after intervention. Method of measurement: Quantitative Real-time Polymerase chain reaction. Changes in beta-galactosidase activity. Timepoint: Before and after intervention. Method of measurement: x-gal staining. Serum IL-6. Timepoint: Before and after intervention. Method of measurement: ELISA KIT. Serum TNFα. Timepoint: Before and after intervention. Method of measurement: ELISA KIT. NLR: Neutrophil to Lymphocyte Ratio. Timepoint: Before and after intervention. Method of measurement: Calculation based on complete blood count with Differential test. C-Reactive Protein. Timepoint: Before and after intervention. Method of measurement: Elisa kit. Shahid Beheshti University of Medical Sciences Approved 2023-08-07 Ethics committee of Shahid Beheshti University of Medical Sciences Floor 6, Block 2, Shahid Beheshti University of Medical Sciences, Arabi Street, Yemen Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)