Condition category
Neonatal Diseases
Date applied
17/06/2004
Date assigned
21/09/2004
Last edited
06/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.mira.org.np/research.htm

Contact information

Type

Scientific

Primary contact

Prof Anthony Costello

ORCID ID

Contact details

30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2261
anthony.costello@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

060394; 99-CH-16

Study information

Scientific title

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

Acronym

MIRA (Mother and Infant Research Activities) - a Nepali Non-Governmental Organisation (NGO): Janakpur Multiple Micronutrient Supplementation Study

Study hypothesis

Neonatal mortality is the biggest contributor to global mortality of children younger than five years, and low birth weight is a crucial underlying factor. This study is a double blind, randomised controlled trial of the effects of antenatal multiple micronutrient supplementation on birth weight, gestation and perinatal infection, conducted in Dhanusha district, Nepal.

Added 15/02/2007:
1. Second and third trimester supplementation with a multiple micronutrient regime will increase birth weight
2. Second and third trimester supplementation with a multiple micronutrient regime will prolong gestation
3. Second and third trimester supplementation with a multiple micronutrient regime will make mothers less susceptible to infection

Ethics approval

Not provided at time of registration

Study design

Double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Low birth weight

Intervention

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 1.4 mg, Niacin 18 mg, Vitamin B6 1.9 mg, Vitamin B12 2.6 mcg, Folic acid 400 mcg, Vitamin C 70 mg, Iron 30 mg, Zinc 15 mg, Copper 2 mg, Selenium 65 mcg, Iodine 150 mcg.

Control arm (600 participants):
Daily government-recommended supplement from enrolment to delivery: Iron 60 mg, Folic acid 400 mcg.

Intervention type

Supplement

Phase

Not Specified

Drug names

Supplements, vitamins

Primary outcome measures

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 outcome measures

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

Overall trial start date

11/08/2002

Overall trial end date

01/07/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1200

Participant 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

Recruitment start date

11/08/2002

Recruitment end date

22/10/2003

Locations

Countries of recruitment

Nepal

Trial participating centre

Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Institute of Child Health (UK)

Sponsor details

30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor type

Research organisation

Website

http://www.ich.ucl.ac.uk/ich/

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/15766997
2. http://www.ncbi.nlm.nih.gov/pubmed/18262041
3. http://www.ncbi.nlm.nih.gov/pubmed/25442690

Publication citations

  1. Osrin D, Vaidya A, Shrestha Y, Baniya RB, Manandhar DS, Adhikari RK, Filteau S, Tomkins A, Costello AM, Effects of antenatal multiple micronutrient supplementation on birthweight and gestational duration in Nepal: double-blind, randomised controlled trial., Lancet, 365, 9463, 955-962, doi: 10.1016/S0140-6736(05)71084-9.

  2. Vaidya A, Saville N, Shrestha BP, Costello AM, Manandhar DS, Osrin D, Effects of antenatal multiple micronutrient supplementation on children's weight and size at 2 years of age in Nepal: follow-up of a double-blind randomised controlled trial., Lancet, 2008, 371, 9611, 492-499, doi: 10.1016/S0140-6736(08)60172-5.

Additional files

Editorial Notes