The effects of antenatal multiple micronutrient supplementation on birth weight, gestation and infection: a double blind, randomised controlled trial conducted in Nepal

Not Applicable

Completed

• Conditions: ow birth weight; Neonatal Diseases; Low birth weight

• Registration Number: ISRCTN88625934
• Lead Sponsor: Institute of Child Health (UK)

Brief Summary

2005 Results article in http://www.ncbi.nlm.nih.gov/pubmed/15766997 Birth weight and duration of gestation 2008 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/18262041 Weight and size of children aged 2 years 2014 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/25442690 Blood pressure, weight and size of children aged 8 years 2018 Other publications in https://pubmed.ncbi.nlm.nih.gov/29527341/ Cognitive function at 12 years (added 27/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2004-07-01
• Study Start: 2004-09-21
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

1. Pregnant women attending for antenatal care at Janakpur Zonal Hospital, Dhanusha District, Nepal

As of 15th February 2007 the following details were added to this trial record:
2. Enrolment at up to 20 weeks zero days gestation
3. Singleton pregnancy
4. No major foetal anomaly detected on obstetric ultrasound at enrolment
5. No pre-existing maternal illness that would be expected to affect foetal growth

Exclusion Criteria

Added 15/02/2007:
1. Pregnancy at gestations greater than 20 weeks zero days
2. Pre-existing maternal illness of a nature likely to affect pregnancy
3. Multiple pregnancy detected by obstetric ultrasound at enrolment
4. Residence potentially inaccessible for home follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Added 15/02/2007:<br> Primary outcomes (1200 participants):<br> 1. Birth weight, length and head circumference measured within 72 hours of birth<br> 2. Gestation at birth calculated on the basis of obstetric ultrasound biometry at enrolment<br>

Secondary Outcome Measures

Name	Time	Method
<br> Added 15/02/2007:<br> 1. Micronutritional Outcomes (200 participants): venous blood collected at 32 weeks gestation for measurement of plasma vitamins A, C, E and ferritin<br> 2. Immunological outcomes (600 participants):<br> 2.1. Clinical indicators of infection at every contact<br> 2.2. Venous blood collected at 32 weeks gestation for measurement of neopterin<br> 2.3. Breast milk collected at one month postpartum for measurement of sodium/potassium ratio<br>