Maternal and Infant Nutrition Interventions in Matlab (MINIMat)

ISRCTN ISRCTN16581394
DOI https://doi.org/10.1186/ISRCTN16581394
Protocol serial number G0501839; ICDDRB Ethical Review Committee numbers 2000-025, 2002-031, 2005-004, 2006-050
Sponsor International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) (Bangladesh)
Funders UNICEF, Styrelsen för Internationellt Utvecklingssamarbete, Medical Research Council (MRC) (UK) (grant ref: G0501839), Swedish Research Council (Sweden), Department for International Development, International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) (Bangladesh), Global Health Research Fund (Japan), Child Health and Nutrition Research Initiative (CHNRI) (Bangladesh), Uppsala Universitet, United States Agency for International Development (USAID) (USA)
Submission date
02/11/2008
Registration date
16/02/2009
Last edited
01/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Lars Åke Persson
Scientific

Women's and Children's Health
International Maternal and Child Health
University Hospital
Uppsala
75185
Sweden

+46 (0)18 611 9294
lars-ake.persson@kbh.uu.se

Study information

Primary study designInterventional
Study designRandomised controlled trial with factorial design (six groups)
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleFood 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
Study acronymMINIMat
Study objectivesEarly (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.
Ethics approval(s)ICDDRB (International Centre for Diarrhoeal Disease Research, Bangladesh) Ethical Review Committee approval received on 27/09/2000 (ref: 2000-025), 2002 (ref: 2002-031), 26/06/2005 (ref: 2005-004) and 21/12/2006 (ref: 2006-050) (protocol numbers refer to different phases in follow-up)
Health condition(s) or problem(s) studiedNutrition-related suboptimal foetal development and growth
InterventionA 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.
Intervention typeSupplement
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

Key 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

Completion date30/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration5300
Key inclusion criteriaWomen (aged 14 - 50 years) in the study area (Matlab) with pregnancy confirmed by urine test and ultrasound with gestational age less than 14 weeks.
Key exclusion criteriaChronic disease that prevented participation in the trial or planned emigration from the area.
Date of first enrolment01/11/2001
Date of final enrolment30/06/2009

Locations

Countries of recruitment

  • Bangladesh
  • Sweden

Study participating centre

Uppsala University
Uppsala
75185
Sweden

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article infant development results: 01/03/2008 Yes No
Results article infant feeding practices results: 01/06/2008 Yes No
Results article household food security results: 01/07/2008 Yes No
Results article maternal hemoglobin, birth weight, and infant mortality results 16/05/2012 Yes No
Results article food insecurity results 01/06/2012 Yes No
Results article substudy arsenic exposure results 01/10/2012 Yes No
Results article child growth and body composition results 13/12/2013 Yes No
Results article social differentials results 07/01/2014 Yes No
Results article thymus development and mortality results 01/02/2014 Yes No
Results article cost-effectiveness results 28/05/2015 Yes No
Results article selenium metabolism results 01/12/2015 Yes No
Results article vitamin B-12, folate, ferritin and zinc results 01/12/2016 Yes No
Results article results 01/12/2018 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

01/04/2019: Publication reference added.
01/11/2016: Publication reference added.

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