Indonesia 2001b.
Study characteristics | ||
Methods | A double‐blinded, randomised placebo‐controlled trial. A factorial design 4‐arm (Zibuvita study) trial and then included a follow‐up study of the infant (the Zinak and Pronak study) | |
Participants | 5736 women who live in Purworejo district of central Java were identified as pregnant from the Indonesian Ministry of Health surveillance. Of these pregnant women, 2173 women at a gestational age of less than (120 days) 17 weeks were eligible for the trial study. After losses to follow‐up, only 2098 delivery and 1956 neonates were analysed in the Zinak and Pronak study. The follow‐up of the children was from birth up to 2 years of age | |
Interventions | Vitamin A (2400RE): n = 484/527 (91.8%)
Zinc (20 mg): n = 477/531 (89.8%)
Vitamin A (2400RE) + zinc (20 mg): n = 495/543 (91.2%)
Placebo: n = 500/523 (95.6%) Women were randomly allocated to 3 treatment groups and placebo group. The treatment groups were given micronutrient capsules from the date of inclusion in the study until delivery. The capsule contained either 2400 RE of vitamin A (as retinyl palmitate) or 20 mg of ZnSO4, or the same dose of both vitamin A and ZnSO4, or placebo. All capsules also contained 2 mg of DL‐a‐tocopherol as an antioxidant and 350 mg of soya bean oil, 20 mg of beeswax and 8 mg of lecithin as capsule filler. The supplements were manufactured by Tishcon Corp. (Westbury, NY, USA) and they were packaged in plastic strips in identical, opaque pink capsules as sufficient supplements for 2 weeks or 1 month. Fieldworkers distributed capsules and monitored compliance at the home of the women by counting the unused capsules |
|
Outcomes |
Maternal outcomes
Pregnancy weight Neonatal outcomes Birthweight Low birthweight; Stillbirths Neonatal deaths; Blue/floppy (neonatal hypoxia); Fever/not drinking Umbilical infection 6‐month Z‐scores 6‐month haemoglobin, plasma retinol, plasma zinc Birth size (weight and length) Small‐for‐gestational age |
|
Notes | Adherence: mean adherence ranged from 71% to 73% across the 4 arms of the study Dates of study: September 1995 ‐ December 1999 Funding sources: sources of financial support: MotherCare, John Snow Inc., Washington, USA and UNICEF, Jakarta, Indonesia; Gadjah Mada University and the University of Newcastle, Newcastle, Australia; and infrastructure support from the Community Health and Nutrition Research Laboratories, Medical School, Gadjah Mada University and Ministry of Health, Republic of Indonesia through the Third Community Health and Nutrition Development Project Loan from the World Bank (IBRD Loan No. 3550‐IND). The development of this manuscript was supported by the Centre for Global Health at Umeå University, FAS and the Swedish Council for Working Life and Social Research (grant number 2006‐1512) Declarations of interest: authors declare no conflict of interest |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Pseudo‐random number‐generator in blocks of 12 |
Allocation concealment (selection bias) | Low risk | Treatment allocation sequence was prepared and held at a remote site |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All investigators, field and laboratory staff and participants were blinded to the treatment code |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported but likely to have been done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 519 of the 1008 women had pregnancies ending between 1 April and 31 October 1997; data available for 503/519 (97%) of these women |
Selective reporting (reporting bias) | Unclear risk | The protocol was not available and there was not enough information to make this judgement |
Other bias | Low risk | No apparent risk of other bias |