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IRCT20210630051751N1 IRCT 2021-10-11 Shiraz University of Medical Sciences Evaluation of the effect of vitamin D supplementation on insulin resistance, lipid profile, thyroid function indices and body composition in overweight and obese patients with hypothyroidism and glucose intolerance Evaluation of the effect of vitamin D supplementation on insulin resistance, lipid profile, thyroid function indices and body composition in overweight and obese patients with hypothyroidism and glucose intolerance 2021-10-12 anticipated 50 Complete https://irct.ir/trial/57768 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using the block randomization method (1: 1 ratio for intervention and control groups). In this method, blocks of two with a rotation will be created. Then one of these blocks is randomly selected to determine the allocated group for the first and second participants. After that, this random block selection process is repeated to determine the sequence of random allocation until the end of the desired sample size. After determining the randomized sequence, these sequences will be placed in sealed envelopes. The process will be done by an out-of-study person familiar with randomization. Then, when a participant enters the study, an envelope will be opened according to the order and the participant's group will be identified, Blinding description: The capsules for the intervention and control group are the same in terms of appearance characteristics such as color, shape, and size. Capsules are named according to the intervention groups with the same names as A and B by someone outside the study who is not aware of the objectives and method of study. Therefore, both the research team and the participant are blinded to receiving the supplement or placebo. 3 Condition 1: Hypothyroidism. Condition 2: Impaired glucose tolerance. Condition 3: Overweight and obesity. Intervention 1: Intervention group: For 12 weeks, receive vitamin D3 supplement daily (containing 4000 IU of vitamin D3, produced by Zahravi Pharmaceutical Company). Intervention 2: For 12 weeks, they receive a placebo (produced by Zahravi Pharmaceutical Company, which is similar in appearance characteristics to the supplement used in the intervention group). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dr. Mohammad Hassan Eftekhari
Faculty of Nutrition and Food Sciences, Zahra Alley, Shiraz
Shiraz Iran (Islamic Republic of) 111 - 71645 00988-7251001 3- 071 H_eftehkari@yahoo.com Shiraz University of Medical Sciences scientific Dr. Mohammad Hassan Eftekhari
Faculty of Nutrition and Food Sciences, Zahra Alley, Shiraz
Shiraz Iran (Islamic Republic of) 111 - 71645 00988-7251001 3- 071 H_eftehkari@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Individuals between 20 and 75 years old. Overweight or obese individuals with a body mass index above 25. Individuals Suffering from hypothyroidism with TSH levels higher than 7 microIU/ml. Individuals with impaired glucose tolerance with fasting plasma glucose levels above 100 mg/dL or 2-hour plasma glucose above 140 mg / dL. Individuals with serum 25-hydroxyvitamin D3 concentration is less than 30 ng/ml. 20 years 75 years Both Individuals with cancer, kidney, liver, cardiovascular, bone, and endocrine diseases other than hypothyroidism and glucose intolerance disorders. Individuals taking drugs related to diseases such as cancer, kidney, liver, heart, and drugs that affect bone metabolism (estrogen, selective estrogen receptor modulator, bisphosphonate, vitamin D, or calcium). Individuals consuming multivitamins-minerals. Pregnant and lactating women. E03 R73.02 E66 Other hypothyroidism Impaired glucose tolerance (oral) Overweight and obesity Treatment - Drugs Placebo Intervention group: For 12 weeks, receive vitamin D3 supplement daily (containing 4000 IU of vitamin D3, produced by Zahravi Pharmaceutical Company). For 12 weeks, they receive a placebo (produced by Zahravi Pharmaceutical Company, which is similar in appearance characteristics to the supplement used in the intervention group). Insulin resistance: A disorder of glucose homeostasis that is defined as a decrease in the sensitivity of adipose tissue, liver, liver, and other body tissues to insulin, despite normal or elevated levels of insulin in the blood. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Using the formula HOMA-IR: [Fasting insulin(mIU/L) × fasting glucose(mg/dL)]/405. Weight: Weight of a person with light minimum possible clothes and without shoes with an accuracy of 100 grams. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Scales. BMI: [Weight(kg)]/[height (cm) * height (cm)]. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Formula. Waist Circumference: the smallest circumference of waist in centimeters. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Tape measure. Serum TSH. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: ELISA. Serum T3. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: ELISA. Serum T4. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Eliza. Fasting serum insulin. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer. Fasting serum glucose. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer. HbA1c. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer. Serum LDL-c. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer. Serum HDL-c. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer. Serum total cholestrol. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer. Serum triglycerides. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer. Body Fat. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Body Analyzer. P.B.F (Percent Body Fat). Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Body Analyzer. Visceral fat. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Body Analyzer. Subcutaneous fat. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Body Analyzer. Waist to Hip Ratio. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Body Analyzer. T.E.E (Total Energy Expenditure). Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Body Analyzer. Serum 25- Hydroxy vitamin D. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: ELISA. Shiraz University of Medical Sciences Approved 2021-06-19 Ethics Committee of Shiraz University of Medical Sciences Shiraz - Zand Alley - Central building of Fars University of Medical Sciences and Health Services Shiraz Fars Iran (Islamic Republic of)