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21 May 2013
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| [ Print-friendly version ] |
| 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 |
| 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 |
| 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 | 18/09/2012 |
| Date ISRCTN assigned | 16/02/2009 |
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