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

ISRCTN	ISRCTN88625934
DOI	https://doi.org/10.1186/ISRCTN88625934
Protocol serial number	060394; 99-CH-16
Sponsor	Institute of Child Health (UK)
Funder	Wellcome Trust

Submission date: 17/06/2004
Registration date: 21/09/2004
Last edited: 27/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Anthony Costello
Scientific

30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone	+44 (0)20 7905 2261
Email	anthony.costello@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Double-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The effects of antenatal multiple micronutrient supplementation on birth weight, gestation and infection: a double blind, randomised controlled trial conducted in Nepal
Study acronym	MIRA (Mother and Infant Research Activities) - a Nepali Non-Governmental Organisation (NGO): Janakpur Multiple Micronutrient Supplementation Study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/07/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1200
Total final enrolment	1200
Key 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
Key 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
Date of first enrolment	11/08/2002
Date of final enrolment	22/10/2003

Locations

Countries of recruitment

United Kingdom
England
Nepal

Study participating centre

Institute of Child Health

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Birth weight and duration of gestation	01/03/2005		Yes	No
Other publications	Weight and size of children aged 2 years	09/02/2008		Yes	No
Other publications	Blood pressure, weight and size of children aged 8 years	01/11/2014		Yes	No
Other publications	Cognitive function at 12 years	28/02/2018	27/10/2022	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the 2005 reference.