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IRCT201212105623N3 IRCT 2012-12-26 Kashan University Of Medical Science Effects of supplementation in treatment of pregnancy complications Comparison of effectiveness of multivitamin, multivitamin-mineral supplements, synbiotic and normal Gaz on pregnancy outcomes in pregnant women 2011-08-10 anticipated 298 Complete https://irct.ir/trial/6033 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline, after balance randomization, subjects will be divided into groups to take either supplements or control. Intervention group 1: Multivitamin-mineral supplements containing 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, 125 mg calcium, 18 mg iron, 100 mg magnesium, daily, for 20 weeks. Control group 1: Multivitamin supplements containing 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, daily, for 20 weeks. Intervention group 2: Synbiotic Gaz containing Lactobacillus sporogenes 107 CFU/g, 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol and 0.05 g stevia per 1 g, 9 g, twice a day for 9 weeks. Control group 2: Normal Gaz, 9 g, twice a day for 9 weeks. Intervention group 3: Multivitamin-mineral supplements containing 4000 IU vitamin A, 11 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.8 mg vitamin B2, 18 mg niacin, 2.8 mg vitamin B6, 800 µg folic acid, 4 µg vitamin B12, 100 mg vitamin C, 250 mg calcium, 27 mg iron, 25 mg zinc, daily, for 20 weeks. Control group 3: Multivitamin supplements containing 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, daily, for 20 weeks. Randomization will be done by the use of computer-generated random numbers, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups. N/A Pregnancy. Intervention 1: Intervention group 1: Multivitamin-mineral supplements containing 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, 125 mg calcium, 18 mg iron, 100 mg magnesium, daily, for 20 weeks. Intervention 2: Control group 1: Multivitamin supplements containing 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, daily, for 20 weeks. Intervention 3: Intervention group 2: Synbiotic Gaz containing Lactobacillus sporogenes 107 CFU/g, 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol and 0.05 g stevia per 1 g, 9 g, twice a day for 9 weeks. Intervention 4: Control group 2: Normal Gaz, 9 g, twice a day for 9 weeks. Intervention 5: Intervention group 3: Multivitamin-mineral supplements containing 4000 IU vitamin A, 11 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.8 mg vitamin B2, 18 mg niacin, 2.8 mg vitamin B6, 800 µg folic acid, 4 µg vitamin B12, 100 mg vitamin C, 250 mg calcium, 27 mg iron, 25 mg zinc, daily, for 20 weeks. Intervention 6: Control group 3: Multivitamin supplements containing 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, daily, for 20 weeks. 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 Undecided - It is not yet known if there will be a plan to make this available.
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 1771844351 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8719844189 +98 36 1446 3378 asemi_za@yahoo.com Kashan University Of Medical Science Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Pregnant women primigravida Aged 18-35 year old who were carrying singleton pregnancy at their second and third trimester 18 years 35 years Female Multiparous women Patients with hypertension Gestational diabetes mellitus (GDM) Complete bed rest (CBR) Intra uterine fetal death (IUFD) Placenta abruption Preterm delivery Intrauterine growth restriction (IUGR) History of rheumatoid arthritis, thyroid, parathyroid or adrenal diseases Hepatic or renal failure Hospitalization Signs of malabsorption and maldigestion Metabolic bone disease 094 Sequelae of complication of pregnancy, childbirth and the puerperium Treatment - Drugs Treatment - Other Treatment - Drugs Other Treatment - Drugs Treatment - Drugs Intervention group 1: Multivitamin-mineral supplements containing 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, 125 mg calcium, 18 mg iron, 100 mg magnesium, daily, for 20 weeks. Control group 1: Multivitamin supplements containing 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, daily, for 20 weeks. Intervention group 2: Synbiotic Gaz containing Lactobacillus sporogenes 107 CFU/g, 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol and 0.05 g stevia per 1 g, 9 g, twice a day for 9 weeks. Control group 2: Normal Gaz, 9 g, twice a day for 9 weeks. Intervention group 3: Multivitamin-mineral supplements containing 4000 IU vitamin A, 11 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.8 mg vitamin B2, 18 mg niacin, 2.8 mg vitamin B6, 800 µg folic acid, 4 µg vitamin B12, 100 mg vitamin C, 250 mg calcium, 27 mg iron, 25 mg zinc, daily, for 20 weeks. Control group 3: Multivitamin supplements containing 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, daily, for 20 weeks. HDL. Timepoint: Baseline and end-of-trial. Method of measurement: Enzymatic kit. Iron. Timepoint: Baseline and end-of-trial. Method of measurement: Enzymatic kit. Total glutathione. Timepoint: Baseline and end-of-trial. Method of measurement: Spectrophotometry. Insulin. Timepoint: Baseline and end-of-trial. Method of measurement: Elisa kit. Newborns' weight. Timepoint: Delivery time. Method of measurement: Scale. Calcium. Timepoint: Baseline and end-of-trial. Method of measurement: Enzymatic kit. Vitamin D. Timepoint: Baseline and end-of-trial. Method of measurement: Elisa kit. Magnesium. Timepoint: Baseline and end-of-trial. Method of measurement: Enzymatic kit. Zinc. Timepoint: Baseline and end-of-trial. Method of measurement: Enzymatic kit. Total antioxidant. Timepoint: Baseline and end-of-trial. Method of measurement: Spectrophotometry. Newborn's head circumference. Timepoint: The first 24 h after birth. Method of measurement: Tape. Newborn's length. Timepoint: The first 24 h after birth. Method of measurement: Tape. Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation. Triglycerides. Timepoint: Baseline and end-of-trial. Method of measurement: Enzymatic kit. Cholesterol. Timepoint: Baseline and end-of-trial. Method of measurement: Enzymatic kit. Insulin resistance. Timepoint: Baseline and end-of-trial. Method of measurement: Using HOMA formula. VLDL. Timepoint: Baseline and end-of-trial. Method of measurement: Enzymatic kit. LDL. Timepoint: Baseline and end-of-trial. Method of measurement: Enzymatic kit. Hs-CRP. Timepoint: Baseline and end-of-trial. Method of measurement: Elisa kit. Kashan University Of Medical Science Approved 2011-08-09 Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)