Periconceptional multiple-micronutrient supplementation and placental function in rural Gambian women: a double-blind, randomized, placebo-controlled trial
What this study found
Periconceptional UNIMMAP produced a modest improvement in uterine-artery vascular indices, but most placental function measures and birth outcomes were unchanged, so the clinical importance remains uncertain. At 18-22 weeks, uterine artery PI was lower with UNIMMAP than placebo (1.12 vs 1.20; difference -0.08, 95% CI -0.16 to -0.01; P = 0.025) and uterine artery RI was also slightly lower (0.61 vs 0.63; P = 0.050). Longitudinally, UNIMMAP reduced UtARI by 0.02 units over 18-32 weeks (95% CI -0.03 to -0.00; P = 0.040), but there was no effect on PAI-1, PAI-2, PAI-1:PAI-2 ratio, hCG, hPL, or…
- Study & population
- Double-blind, randomized, placebo-controlled trial in rural Gambian women of reproductive age who were menstruating and not pregnant at enrollment.
- Intervention
- The active intervention was UNIMMAP, a coated multiple-micronutrient tablet containing 15 vitamins and trace elements.
- Key limitation
- The key biological effects were small, and several analyses used reduced sample sizes, which limits precision.
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Open PDFOriginal abstract
Background: Maternal micronutrient deficiencies are commonly associated with clinical indicators of placental dysfunction. Objective: We tested the hypothesis that periconceptional multiple-micronutrient supplementation (MMS) affects placental function. Design: We conducted a double-blind, randomized, placebo-controlled trial of MMS in 17- to 45-y-old Gambian women who were menstruating regularly and within the previous 3 mo. Eligible subjects were pre–randomly assigned to supplementation with the UNICEF/WHO/United Nations University multiple micronutrient preparation (UNIMMAP) or placebo on recruitment and until they reached their first antenatal check-up or for 1 y if they failed to conceive. Primary outcome measures were midgestational indexes of utero-placental vascular-endothelial function [ratio of plasminogen-activator inhibitor (PAI) 1 to PAI-2 and mean uterine-artery resistance index (UtARI)] and placental active transport capacity at delivery [fetal to maternal measles antibody (MMA) ratio]. Results: We recruited 1156 women who yielded 415 pregnancies, of which 376 met all of the inclusion criteria. With adjustment for gestational age at sampling, there were no differences in PAI-1 to PAI-2 or MMA ratios between trial arms, but there was a 0.02-unit reduction in UtARI between 18 and 32 wk of gestation (95% CI: −0.03, −0.00; P = 0.040) in women taking UNIMMAP. Conclusions: Placental vascular function was modifiable by periconceptional micronutrient supplementation. However, the effect was small and supplementation did not further affect other variables of placental function. This trial was registered at www.controlled-trials.com as ISRCTN 13687662.