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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88625934
Enrollment
1200
Registered
2004-09-21
Start date
2002-08-11
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Low birth weight Neonatal Diseases Low birth weight

Interventions

Intervention arm (600 participants): Daily multiple micronutrient tablet from enrolment to delivery: Vitamin A 800 mcg, Vitamin E 10 mg, Vitamin D 5 mcg, Vitamin B1 1.4 mg, Vitamin B2

Sponsors

Institute of Child Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

England, Nepal, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 13, 2026