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IRCT2016121831449N1 IRCT 2017-05-08 Ministry of Health, Nutrition Deprtment Effect of vitamin D supplementation on metabolic syndrome in elderlies The Effect of Vitamin D Supplementation on Metabolic Syndrome Indicators among Food In-secured, Vitamin D Deficient ; A Randomised Clinical Trial 2017-04-21 anticipated 120 Complete https://irct.ir/trial/24731 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Simple allocation randomisation will be accomplished with no stratification using a restricted (10 blocks) random number to ensure equivalence of numbers in each group using www.graphpad.com/quickcalcs/randomn2.cfm. Simple allocation randomization will be accomplished with no stratification using a restricted (10 blocks) random number to ensure equivalence of numbers in each group using www.graphpad.com/quickcalcs/randomn2.cfm. From 120 respondents (60 respondents for each group), the odd numbers will be allocated to group intervention and the even numbers to group control. In every 10 number blocks from the random table, the sequence will be checked to ensure the even numbers are equal to the odd numbers. Each number in the random table will be given a study number and assigned into one of the study groups. A table for the allocation of the participants in the study will be composed and kept in a sealed envelope. Numbered, identical, opaque sealed envelopes will be used for respondents’ allocation. The allocation envelope contains the treatment allocation identification showing either group 1 or group 2. N/A Metabolic syndrome (diabetes, obesity, blood pressure and hyperlipidemia). Intervention 1: Intervention group: The respondents in intervention group will receive 50000 vitamin D for 8 weeks. Plus, brochures and pamphlets related to nutrition and health. Intervention 2: Control group: The respondents in control group will receive placebo per week for 8 weeks. Plus brochures and pamphlets related to nutrition and health at the beginning of the study.
public Mostafa Qorbani
Taleghani Boulevard.
Karaj Iran (Islamic Republic of) +98 912 585 5021 mqorbani1379@yahoo.com Alborz Medical university scientific Maryam Zarei
Block A, Floor 10, East Ivanak, Farahzadi Boulevard,
Tehran Iran (Islamic Republic of) +98 21 8145 4979 maryam.zarei@gmail.com Ministry of Health and Medical Education , Nutrition Department Iran (Islamic Republic of) Inclusion criteria: Food insecure, waist Circumference>90 cm, body mass index ≥30 kg/m2, fasting blood sugar>100 mg/dl, high blood pressure (systolic >135 mmHg and diastolic >85 mmHg) and dyslipidaemia (Low density lipoprotein≥ 240 mg/dl, high density lipoprotein<40 mg/dl, total cholesterol≥ 160 mg/dl, triglyceride ≥ 200 mg/dl), serum 25(OH) D level <30 ng/ml, no use of vitamin D supplementation before 60 days. Exclusion criteria: An inability or unwillingness to participate, those who are already taking any type of vitamin D supplements, Individuals with a history of allergy, those subjects with serious medical condition such as cancer, heart attack, stroke, and etc., illness that required corticosteroids or insulin, drugs are known to influence vitamin D level, steroids, anti-acids, oestrogen, people with conditions that contradict vitamin D supplementation, for example, a history of hypocalcaemia, hepatic disease or renal stones, sarcoidosis, or malignancy. 60 years 80 years Both E10, E11, Metabolic disorders and nutritional Treatment - Drugs Placebo Intervention group: The respondents in intervention group will receive 50000 vitamin D for 8 weeks. Plus, brochures and pamphlets related to nutrition and health. Control group: The respondents in control group will receive placebo per week for 8 weeks. Plus brochures and pamphlets related to nutrition and health at the beginning of the study. 25(OH)D. Timepoint: 8 weeks. Method of measurement: blood taking (before intervention and after intervention, 2 months later). Fasting Blood Pressure (FBS). Timepoint: 8 weeks. Method of measurement: blood taking before and after intervention (2months). Antropometrics indicators. Timepoint: 8 weeks. Method of measurement: measuring height and weight before and after intervention (2months). Blood Pressure. Timepoint: 8 weeks. Method of measurement: measure before and after intervention (2months). Hyperlipidemia. Timepoint: 8 weeks. Method of measurement: blood taking before and after intervention (2months). Ministry of Health, Nutrition Deprtment Approved 2017-02-13 Research deputy Alborz Medical university Taleghani Boulevard Karaj Iran (Islamic Republic of)