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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
ISRCTN ISRCTN88625934
DOI 10.1186/ISRCTN88625934
ClinicalTrials.gov identifier
EudraCT number
Public title The effects of antenatal multiple micronutrient supplementation on birth weight, gestation and infection: a double blind, randomised controlled trial conducted in Nepal
Scientific title
Acronym MIRA (Mother and Infant Research Activities) - a Nepali Non-Governmental Organisation (NGO): Janakpur Multiple Micronutrient Supplementation Study
Serial number at source 060394; 99-CH-16
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.

As of the 15th February 2007, the following hypotheses were added to this trial record:
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
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Double-blind, randomised controlled trial
Countries of recruitment Nepal
Disease/condition/study domain Low birth weight
Participants - 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
Participants - exclusion criteria As of 15th February 2007 the following details were added to this trial record:
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
Anticipated start date 11/08/2002
Anticipated end date 01/07/2004
Status of trial Completed
Patient information material
Target number of participants 1200 - recruitment ends on the 22nd October 2003
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 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.
Primary outcome measure(s) As of 15th February 2007 the following details were added to this trial record:

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 measure(s) As of 15th February 2007 the following details were added to this trial record:

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):
a. clinical indicators of infection at every contact
b. venous blood collected at 32 weeks gestation for measurement of neopterin
c. breast milk collected at one month postpartum for measurement of sodium/potassium ratio
Sources of funding The Wellcome Trust (UK) (grant ref: 060394)
Trial website http://www.mira.org.np/research.htm
Publications Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/15766997
2. http://www.ncbi.nlm.nih.gov/pubmed/18262041
Contact name Prof  Anthony  Costello
  Address 30 Guilford Street
  City/town London
  Zip/Postcode WC1N 1EH
  Country United Kingdom
  Tel +44 (0)20 7905 2261
  Fax +44 (0)20 7404 2062
  Email anthony.costello@ucl.ac.uk
Sponsor Institute of Child Health (UK)
  Address 30 Guilford Street
  City/town London
  Zip/Postcode WC1N 1EH
  Country United Kingdom
  Sponsor website: http://www.ich.ucl.ac.uk/ich/
Date applied 17/06/2004
Last edited 11/03/2013
Date ISRCTN assigned 21/09/2004
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