Condition category
Pregnancy and Childbirth
Date applied
02/11/2008
Date assigned
16/02/2009
Last edited
15/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.minimat.org

Contact information

Type

Scientific

Primary contact

Prof Lars Åke Persson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0501839; ICDDRB Ethical Review Committee numbers 2000-025, 2002-031, 2005-004, 2006-050

Study information

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

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.

Ethics approval

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)

Study design

Randomised controlled trial with factorial design (six groups)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Iron, folic acid, multiple micronutrient supplement (MMS) (iron, folic acid, vitamin A, vitamin D, vitamin E, vitamin C, vitamin B1, vitamin B2, niacin, vitamin B6, vitamin B12, zinc, copper, selenium, iodine)

Primary outcome measures

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 trial start date

01/11/2001

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

5300

Participant exclusion criteria

Chronic disease that prevented participation in the trial or planned emigration from the area.

Recruitment start date

01/11/2001

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Bangladesh

Trial participating centre

Women's and Children's Health
Uppsala
75185
Sweden

Sponsor information

Organisation

International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) (Bangladesh)

Sponsor details

68 Shahid Tajuddin Ahmed Sharani
Mohakhali (GPO Box 128
Dhaka 1000)
Dhaka
1212
Bangladesh

Sponsor type

Research organisation

Website

http://www.icddrb.org

Funders

Funder type

Research organisation

Funder name

United Nations Children's Fund (UNICEF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish International Development Cooperation Agency (Sida) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (MRC) (UK) (grant ref: G0501839)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Swedish Research Council (Sweden)

Alternative name(s)

Swedish Research Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Department for International Development (DfID) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) (Bangladesh)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Global Health Research Fund (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Child Health and Nutrition Research Initiative (CHNRI) (Bangladesh)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Uppsala University (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

United States Agency for International Development (USAID) (USA)

Alternative name(s)

USAID

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 infant development results: http://www.ncbi.nlm.nih.gov/pubmed/18326610
2. 2008 infant feeding practices results: http://www.ncbi.nlm.nih.gov/pubmed/18541577
3. 2008 household food security results: http://www.ncbi.nlm.nih.gov/pubmed/18567765
4. 2012 maternal hemoglobin, birth weight, and infant mortality 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. 2013 child growth and body composition results in: http://www.ncbi.nlm.nih.gov/pubmed/24331714
8. 2014 social differentials results in http://www.ncbi.nlm.nih.gov/pubmed/24393610

Publication citations

  1. Infant development results

    Tofail F, Persson LA, El Arifeen S, Hamadani JD, Mehrin F, Ridout D, Ekström EC, Huda SN, Grantham-McGregor SM, Effects of prenatal food and micronutrient supplementation on infant development: a randomized trial from the Maternal and Infant Nutrition Interventions, Matlab (MINIMat) study., Am. J. Clin. Nutr., 2008, 87, 3, 704-711.

  2. Infant feeding practices results

    Saha KK, Frongillo EA, Alam DS, Arifeen SE, Persson LA, Rasmussen KM, Appropriate infant feeding practices result in better growth of infants and young children in rural Bangladesh., Am. J. Clin. Nutr., 2008, 87, 6, 1852-1859.

  3. Household food security results

    Saha KK, Frongillo EA, Alam DS, Arifeen SE, Persson LA, Rasmussen KM, Household food security is associated with infant feeding practices in rural Bangladesh., J. Nutr., 2008, 138, 7, 1383-1390.

  4. Food insecurity results

    Frith AL, Naved RT, Persson LA, Rasmussen KM, Frongillo EA, Early participation in a prenatal food supplementation program ameliorates the negative association of food insecurity with quality of maternal-infant interaction., J. Nutr., 2012, 142, 6, 1095-1101, doi: 10.3945/jn.111.155358.

  5. Substudy arsenic exposure results

    Ahmed S, Ahsan KB, Kippler M, Mily A, Wagatsuma Y, Hoque AM, Ngom PT, El Arifeen S, Raqib R, Vahter M, In utero arsenic exposure is associated with impaired thymic function in newborns possibly via oxidative stress and apoptosis., Toxicol. Sci., 2012, 129, 2, 305-314, doi: 10.1093/toxsci/kfs202.

  6. Child growth and body composition results

    Islam Khan A, Effects of pre- and postnatal nutrition interventions on child growth and body composition: the MINIMat trial in rural Bangladesh., Glob Health Action, 2013, 6, 22476.

  7. Social differentials results

    Shaheen R, Streatfield PK, Naved RT, Lindholm L, Persson LA, Equity in adherence to and effect of prenatal food and micronutrient supplementation on child mortality: results from the MINIMat randomized trial, Bangladesh., BMC Public Health, 2014, 14, 5, doi: 10.1186/1471-2458-14-5.

  8. Persson LÅ, Arifeen S, Ekström EC, Rasmussen KM, Frongillo EA, Yunus M, , Effects of prenatal micronutrient and early food supplementation on maternal hemoglobin, birth weight, and infant mortality among children in Bangladesh: the MINIMat randomized trial., JAMA, 2012, 307, 19, 2050-2059, doi: 10.1001/jama.2012.4061.

Additional files

Editorial Notes