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. 2015 Feb 2;2015(2):CD000230. doi: 10.1002/14651858.CD000230.pub5

Indonesia 2001.

Methods A double‐blinded, RCT. A follow‐up study of the infants with a factorial design. A 4‐arm trial.
Participants 230 pregnant women were recruited before 20 weeks of gestational age from 13 adjacent villages in Bogor District, Indonesia. Of 230 women, 179 women remain until delivery and only and only 170 women were enrolled for follow up of infant and mother until 6 months postpartum study. Each woman was supplemented daily during pregnancy until delivery. Exclusion criteria at enrolment were twin pregnancy and congenital abnormalities. Women had mean plasma zinc concentrations of about 11 µmol/L.
Interventions All women received iron and folic acid (30 mg iron as ferrous fumarate/d and 0.4 mg pteroylglutamic acid/d). In addition, 1 group of women received ß‐carotene (4.5 mg as water‐soluble granulate/d; ß‐carotene group), 1 group received zinc (30 mg zinc as sulphate/day; zinc group), 1 group received ß‐carotene plus zinc (4.5 mg ß‐carotene and 30 mg zinc/d; ß‐carotene + zinc group), and 1 group received only iron and folic acid (control group). Capsules were prepared by the pharmacy of the Gelderse Vallei Hospital (Ede, Netherlands) and given a letter code and the micronutrients were indistinguishable from each other. Compliance, expressed as a proportion of the intended supplements consumed during pregnancy, did not differ among the groups with a mean compliance of > 80% in all groups, and 90% of the women taking > 50% of the intended dose.
 Iron + folate acid: (n = 41).
 Iron + folate acid + β‐carotene: (n = 43).
 Iron + folate acid + zinc: (n = 44).
 Iron + folate acid + β‐carotene + zinc (n = 42).
Outcomes Maternal outcomes

Preterm birth;

caesarean section;

prolonged labour;

retention of placenta;

postpartum haemorrhage;

infection;

6‐month serum zinc.
 Neonatal outcomes

Birthweight;

low birthweight;

congenital malformation;

stillbirth/neonatal death;

blue/floppy (neonatal hypoxia);

jaundice;

fever/not drinking;

umbilical infection;

6‐month Z‐scores;

6‐month haemoglobin;
plasma retinol;
plasma zinc.
Notes Adherence: mean adherence was over 80%.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation not reported.
Allocation concealment (selection bias) Unclear risk Supplements were prepared by a third party (hospital pharmacy in the Netherlands), but no detail given of how the contents of the bottles were concealed from the investigators or the participants.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Stated as being "double‐blind"; probably done.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Losses to follow‐up: 50/229 (22%) women before giving birth; 136 newborns completed follow‐up at 6 months.
Selective reporting (reporting bias) Unclear risk Not all expected maternal primary outcomes reported, but most primary infant outcomes specified in the review were reported.
Other bias Low risk No apparent risk of other bias.