Comparison of effectiveness of multivitamin, multivitamin-mineral supplements, synbiotic and normal Gaz on pregnancy outcomes in pregnant women

Objective: This study is to determine the effects of multivitamin, multivitamin-mineral and synbiotic Gaz supplementation on pregnancy outcomes.

Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.

Population and sample size: 298 pregnant women of eligible and referred to Naghavi, Shahid Beheshti Clinics, and antenatal centers affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.

Inclusion Criteria: Pregnant women primigravida, aged 18-35 year old who were carrying singleton pregnancy at their second and third trimester. Exclusion Criteria: 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.

Intervention: Patients will be assigned to receive either multivitamin-mineral (n=27) or multivitamin (n=27), multivitamin-mineral (n=55) or multivitamin (n=55), multivitamin-mineral (n=39) or multivitamin (n=39), synbiotic Gaz (n=28) or normal Gaz (n=28). Supplements capsules and Gaz are similar in shape and size.

Outcomes: Iron, newborns' weight, HDL, insulin and glutathione (primary outcomes), and insulin metabolism parameters, lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.

Kashan University of Medical Sciences

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.

Participants, investigators or the assessors of the outcomes are unaware of the study groups.