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A Double-blind, Randomized, Placebo-Controlled Trial

Piyush Gupta, MD, MAMS; Mily Ray, MD; Tarun Dua, MD; Gita Radhakrishnan, MD; Rajeev Kumar, MSc; H. P. S. Sachdev, MD, FAMS

Arch Pediatr Adolesc Med. 2007;161(1):58-64.

Objective  To evaluate the effect of multimicronutrient supplementation for undernourished pregnant women on the birth size of their offspring, incidence of low-birth-weight infants (<2500 g), and early neonatal morbidity.

Design  Randomized, double-blind, placebo-controlled trial.

Setting  Tertiary care hospital.

Participants  Two hundred pregnant women (of 13 465 approached) with a body mass index (calculated as weight in kilograms divided by the square of height in meters) of less than 18.5 and/or a hemoglobin level of 7 to 9 g/dL were enrolled at 24 to 32 weeks of gestation. One hundred forty-six neonates (73.0%) were available for analysis of birth size and 170 (85.0%) for analysis of morbidity in the 7 days after delivery.

Intervention  The micronutrient supplementation group (n = 99) received a multimicronutrient supplement containing 29 vitamins and minerals once a day, from enrollment until delivery (median duration, 58 days; interquartile range, 37-77 days; compliance, 87%). The comparison group (n = 101) received placebo for 52 (15-66) days, with 85% compliance. All subjects also received supplements of iron (given in the form of ferrous sulfate, containing 60 mg of elemental iron), 60 mg/d, and folic acid, 500 µg/d.

Main Outcome Measures  Birth weight, length, midarm circumference, incidence of low birth weight, and early neonatal morbidity.

Results  Infants in the micronutrient group were heavier by 98 g (95% confidence interval [CI], –16 to 213 g) and measured 0.80 cm (95% CI, 0.03-1.57 cm) longer and 0.20 cm (95% CI, 0.04-0.36 cm) larger in midarm circumference compared with the placebo group. Incidence of low birth weight declined from 43.1% to 16.2% with multimicronutrient supplementation a (a 70% decrease; relative risk, 0.30; 95% CI, 0.13-0.71; P=.006), and that of early neonatal morbidity declined from 28.0% to 14.8% (a 58% decrease; relative risk, 0.42; 95% CI, 0.19-0.94; P=.04).

Conclusion  Compared with iron and folic acid supplementation, the administration of multimicronutrients to undernourished pregnant women may reduce the incidence of low birth weight and early neonatal morbidity.

Author Affiliations: Departments of Pediatrics (Drs Gupta, Ray, and Dua), Obstetrics and Gynecology (Dr Radhakrishnan), and Biostatistics (Mr Kumar), University College of Medical Sciences, Delhi, India; and Pediatric and Clinical Epidemiology Unit, Sitaram Bhartia Institute of Science and Research, New Delhi, India (Dr Sachdev).

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