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Maternal and Infant Nutrition Interventions in Matlab (MINIMat)
ISRCTN ISRCTN16581394
DOI 10.1186/ISRCTN16581394
ClinicalTrials.gov identifier
EudraCT number
Public title Maternal and Infant Nutrition Interventions in Matlab (MINIMat)
Scientific title Food and multiple micronutrient supplementation to pregnant women in rural Bangladesh with follow up on foetal and child growth, infant and child mortality, immune function, morbidity and cognitive development: a randomised trial with a factorial design
Acronym MINIMat
Serial number at source G0501839; ICDDRB Ethical Review Committee numbers 2000-025, 2002-031, 2005-004, 2006-050
Study hypothesis Early (first trimester) invitation to daily prenatal food supplementation to undernourished women combined with multiple micronutrient supplementation improve foetal growth, infant survival and later selected functional outcomes as compared to usual (third trimester) invitation to food supplementation and standard program iron-folate supplements.
Lay summary Not provided at time of registration
Ethics approval ICDDRB (International Centre for Diarrhoeal Disease Research, Bangladesh) Ethical Review Committee approval received on 27th September 2000 (ref: 2000-025), 2002 (ref: 2002-031), 26th June 2005 (ref: 2005-004) and 21st December 2006 (ref: 2006-050) (protocol numbers refer to different phases in follow-up).
Study design Randomised controlled trial with factorial design (6 groups)
Countries of recruitment Bangladesh
Disease/condition/study domain Nutrition-related suboptimal foetal development and growth
Participants - inclusion criteria Women (aged 14 - 50 years) in the study area (Matlab) with pregnancy confirmed by urine test and ultrasound with gestational age less than 14 weeks.
Participants - exclusion criteria Chronic disease that prevented participation in the trial or planned emigration from the area.
Anticipated start date 01/11/2001
Anticipated end date 30/06/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 5300
Interventions A randomised factorial experiment was conducted to evaluate effects of food and mirconutrient supplements during pregnancy on health outcomes of the women and their newborn infants. There were two food groups and three micronutrient groups resulting in a total of 6 groups. The two food supplement groups were to start supplementation:
1. Immediately after diagnosis of pregnancy (early assignment), or
2. At the time of their choosing (usual care in this community)

The three types of micronutrient supplements were:
1. 30 mg iron and 400 ug of folic acid (Fe30F)
2. 60 mg of iron and 400 ug of folic acid, (Fe60F)
3. Multiple micronutrient supplement (MMS) containing 15 micronutrients as recommended by United Nations Children's Fund (UNICEF)/World Health Organization (WHO)/United Nations University (UNU): 30 mg iron, 400 µg folic acid, 800 µg RE vitamin A, 200 IU vitamin D, 10 mg vitamin E, 70 mg vitamin C, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 µg vitamin B12, 15 mg zinc, 2 mg copper, 65 µg selenium and 150 µg iodine.

At around 9 weeks of pregnancy women were randomly allocated to either early invitation to food supplementation (i.e. 9 weeks) or to the usual program start (at around 17 weeks). Food supplementation continued up to end of pregnancy. At 13 weeks of gestation women were randomly and double-masked allocated to the three different micronutrient supplementations that continued for the entire pregnancy.
Primary outcome measure(s) 1. Size at birth, measured within 72 hours
2. Gestational age at birth
3. Infant mortality, prospectively assessed up to 1 year of age
4. Maternal haemoglobin and micronutrient status in third trimester, measured at 30 weeks of gestation
Secondary outcome measure(s) 1. Growth, measured every month up to 1 year, thereafter every 3 months to 24 months and at 4.5 years, and cognitive development, measured at 7 months, 18 months and 4.5 years
2. Micronutrient status, measured at 6 months and 4.5 years of age
3. Immune function, measured at 4.5 years of age, and morbidity, measured monthly with 1-week recall up to 1 years, thereafter 3-monthly up to 2 years and at 4.5 years
4. Blood pressure at 4.5 years
5. Metabolic markers at 4.5 years
6. Mothers are followed with anthropometry into the next pregnancy (when applicable), measured 6 months after delivery when becoming pregnant again
Sources of funding 1. United Nations Children's Fund (UNICEF)
2. Swedish International Development Cooperation Agency (Sida) (Sweden)
3. Medical Research Council (MRC) (UK) (grant ref: G0501839)
4. Swedish Research Council (Sweden)
5. Department for International Development (DfID) (UK)
6. International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) (Bangladesh)
7. Global Health Research Fund (Japan)
8. Child Health and Nutrition Research Initiative (CHNRI) (Bangladesh)
9. Uppsala University (Sweden)
10. United States Agency for International Development (USAID) (USA)
Trial website http://www.minimat.org
Publications Results:
1. 2008 infant development results: http://www.ncbi.nlm.nih.gov/pubmed/18326610
2. 2008 infant feeding practices: http://www.ncbi.nlm.nih.gov/pubmed/18541577
3. 2008 household food security: http://www.ncbi.nlm.nih.gov/pubmed/18567765
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22665104
5. 2012 food insecurity results in http://www.ncbi.nlm.nih.gov/pubmed/22496401
6. 2012 substudy arsenic exposure results in http://www.ncbi.nlm.nih.gov/pubmed/22713597
7. 2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24393610
Contact name Prof  Lars Åke  Persson
  Address Women's and Children's Health
International Maternal and Child Health
University Hospital
  City/town Uppsala
  Zip/Postcode 75185
  Country Sweden
  Tel +46 (0)18 611 9294
  Fax +46 (0)18 508 013
  Email lars-ake.persson@kbh.uu.se
Sponsor International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) (Bangladesh)
  Address 68 Shahid Tajuddin Ahmed Sharani
Mohakhali (GPO Box 128, Dhaka 1000)
  City/town Dhaka
  Zip/Postcode 1212
  Country Bangladesh
  Sponsor website: http://www.icddrb.org
Date applied 02/11/2008
Last edited 09/01/2014
Date ISRCTN assigned 16/02/2009
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