Which iron supplementation regime for pregnant women provides the best maternal and infant outcomes?

A randomised controlled trial to compare the impact on birth weight of daily iron-folic acid, twice weekly iron-folic acid and twice weekly multiple micronutrient supplementation for pregnant women in Ha Nam province, Vietnam.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000944033

Enrollment

1258

Registered

2010-11-04

Start date

2010-09-28

Completion date

2010-11-05

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In this study, we will compare the effects of three different methods of iron supplementation in 1250 pregnant Vietnamese women on maternal haemoglobin and iron stores, infant birth weight, and infant anaemia, infant height, weight and developmental screening during the first 12 months of life. We will also assess the influence of maternal depression on infant growth parameters.

Interventions

The trial has three arms. Arms 1. and 2. will each receive a different intervention as follows: 1. Micronutrient supplement (elemental iron 60mg, folic acid 1.5mg) taken orally twice weekly for the duration of pregnancy and three months postpartum. and 2. Micronutrient supplement (multiple micronutrients - modified 2xUNIMAPP) taken orally twice weekly for the duration of pregnancy and three months postpartum.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

Inclusion criteria

healthy pregnant women 16 weeks gestation or less

Exclusion criteria

complicated pregnancies (e.g. twins, diabetes, other medical conditions), or Hb<=8.0

Outcome results