Maternal and Infant Nutrition Interventions in Matlab (MINIMat)
| ISRCTN | ISRCTN16581394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16581394 |
| Secondary identifying numbers | G0501839; ICDDRB Ethical Review Committee numbers 2000-025, 2002-031, 2005-004, 2006-050 |
- 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
Scientific
Women's and Children's Health
International Maternal and Child Health
University Hospital
Uppsala
75185
Sweden
| Phone | +46 (0)18 611 9294 |
|---|---|
| lars-ake.persson@kbh.uu.se |
Study information
| Study design | Randomised controlled trial with factorial design (six groups) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | MINIMat |
| Study objectives | 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. |
| 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) studied | Nutrition-related suboptimal foetal development and growth |
| Intervention | 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. |
| Intervention type | Supplement |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/11/2001 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 5300 |
| Key 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. |
| Key exclusion criteria | Chronic disease that prevented participation in the trial or planned emigration from the area. |
| Date of first enrolment | 01/11/2001 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- Bangladesh
- Sweden
Study participating centre
Uppsala University
Uppsala
75185
Sweden
75185
Sweden
Sponsor information
International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) (Bangladesh)
Research organisation
Research organisation
68 Shahid Tajuddin Ahmed Sharani
Mohakhali (GPO Box 128, Dhaka 1000)
Dhaka
1212
Bangladesh
| Website | http://www.icddrb.org |
|---|---|
"ROR" |
https://ror.org/04vsvr128 |
Funders
Funder type
Research organisation
UNICEF
Government organisation / International organizations
Government organisation / International organizations
- Alternative name(s)
- United Nations Children's Fund, United Nations Children's Emergency Fund, Fonds des Nations Unies pour l'enfance, Fondo de las Naciones Unidas para la Infancia, صندوق الأمم المتحدة للطفولة, 联合国儿童基金会
- Location
- United States of America
Styrelsen för Internationellt Utvecklingssamarbete
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- Swedish International Development Cooperation Agency, Swedish Development Cooperation, The Swedish International Development Cooperation Agency, Sida
- Location
- Sweden
Medical Research Council (MRC) (UK) (grant ref: G0501839)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Swedish Research Council (Sweden)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
Department for International Development
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Department for International Development, UK, DFID
- Location
- United Kingdom
International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) (Bangladesh)
No information available
Global Health Research Fund (Japan)
No information available
Child Health and Nutrition Research Initiative (CHNRI) (Bangladesh)
No information available
Uppsala Universitet
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Uppsala University, UU_University, Uppsala Universitet, Sweden, UU
- Location
- Sweden
United States Agency for International Development (USAID) (USA)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- U.S. Agency for International Development, Agency for International Development, USAID
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 |
Editorial Notes
01/04/2019: Publication reference added.
01/11/2016: Publication reference added.
