Contact information
Type
Scientific
Primary contact
Dr Anuraj Shankar
ORCID ID
Contact details
Department of Nutrition
Harvard School of Public Health
665 Huntington Ave
Boston MA
02115
United States of America
+1 617 432 4028
ashankar@hsph.harvard.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Supplementation with Multiple Micronutrients Intervention Trial
Acronym
SUMMIT
Study hypothesis
Initial study:
Prenatal multivitamin supplementation, in comparison to iron/folate supplements, will reduce maternal mortality, infant mortality, and improve birth weight.
10 year follow-up study:
10-year follow-up of the Supplementation with Multiple Micronutrients Intervention Trial (Summit), the Summit Institute of Development (SID) in Mataram, Indonesia will assess the health and cognitive development of children at 8-11 years of age whose mothers had consumed multiple micronutrient supplements, as compared to iron and folic acid, during pregnancy and 3 months postpartum.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Maternal and infant mortality and morbidity, and birth weight
Intervention
Initial study:
Prenatal supplementation with either iron and folate or with a multivitamin containing iron, folate, vitamins A, B1, B2, B6, B12, C, D and E, along with niacin, zinc, copper, selenium, and iodine
10 Year follow-up study:
Nearly 30,000 children will be assessed for school performance, mortality and morbidity, with approximately 3,000 of these to be evaluated for cognition, developmental status, and physiological and immune function. The scientists, including Husni Muadz (University of Mataram), Anuraj Shankar (Harvard University), Elizabeth Prado (UC Davis), Susy Sebayang, Mandri Apriatni and Ben Harefa (SID), Michael Ullman (Georgetown University), and Katie Alcock (Lancaster University), aim to document the scope and pathways whereby maternal nutrition may have long term effects on human potential, thereby providing needed evidence to inform global policy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Miscarriage
2. Stillbirth
3. Perinatal mortality
4. Neonatal mortality
5. Early neonatal mortality
6. Late neonatal mortality
7. Infant mortality
8. Maternal mortality
9. Preterm birth
10. Birthweight
11. Low birthweight
Secondary outcome measures
Current secondary outcome measures as of 31/12/2014:
1. Child motor, cognitive, and socio-emotional development and health and morbidity at 9-12 years
2. Child anthropometry and nutritional status at 9-12 years
3. Child hemoglobin concentration at 9-12 years
4. An adapted version of the Home Observation for the Measurement of the Environment (HOME) as an indicator of the household cognitive development environment at 9-12 years
5. Maternal socio-emotional status at 9-12 years
6. Child biochemical nutritional status and biochemical markers of stress and immune function at 9-12 years
7. Child activity level, physiologic regulation and anatomical complexity at 9-12 years
Previous secondary outcome measures as of 03/03/2011:
1. Maternal Cognition and Mood
2. Child Motor, Cognitive, and Socio-Emotional Development and Health and Morbidity at age 42 months
3. Child Anthropometry and nutritional status, including dietary habits, at age 42 months
4. Child Hemoglobin concentration at age 42 months
5. An adapted version of the Home Observation for the Measurement of the Environment (HOME) as an indicator of the household cognitive development environment
6. Weight gain during pregnancy
7. Maternal biochemical nutritional status and biochemical markers of pregnancy progression
Previous secondary outcome measures:
1. Hemoglobin levels
a. At 36 weeks gestational age
b. Within 1 week of birth
c. At 12 weeks post-partum
d. Within 1 month of enrollment by 1st, 2nd, and 3rd trimester of enrollment
2. Gestational age
3. Head circumference
4. Maternal and infant morbidity
5. Cause of death
6. Maternal malaria
Overall trial start date
01/07/2001
Overall trial end date
31/12/2014
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant women and their infants.
Inclusion criteria: Confirmed pregnancy of any gestational age by physical exam or urine test and consenting to be involved in the study.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
42,000
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/07/2001
Recruitment end date
30/04/2004
Locations
Countries of recruitment
Indonesia
Trial participating centre
Department of Nutrition
Boston MA
02115
United States of America
Funders
Funder type
Other
Funder name
Turner Foundation, United Nations Children's Fund (UNICEF), US Agency for International Development (USAID), Helen Keller International, Center for Health and Human Development (CHHD)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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 results in http://www.ncbi.nlm.nih.gov/pubmed/18207017
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18406846
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20496613
4. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20120794
5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20120795
6. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20120796
7. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19772714
8. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21673719
9. 2012 substudy maternal mood and cognition results in http://www.ncbi.nlm.nih.gov/pubmed/22427850
10. 2012 substudy results on child cognition in http://www.ncbi.nlm.nih.gov/pubmed/22908103
11. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22943372
Publication citations
-
Results
, Shankar AH, Jahari AB, Sebayang SK, Aditiawarman, Apriatni M, Harefa B, Muadz H, Soesbandoro SD, Tjiong R, Fachry A, Shankar AV, Atmarita, Prihatini S, Sofia G, Effect of maternal multiple micronutrient supplementation on fetal loss and infant death in Indonesia: a double-blind cluster-randomised trial., Lancet, 2008, 371, 9608, 215-227, doi: 10.1016/S0140-6736(08)60133-6.
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Results
Shankar A, Sebayang S, Guarenti L, Utomo B, Islam M, Fauveau V, Jalal F, The village-based midwife programme in Indonesia., Lancet, 2008, 371, 9620, 1226-1229, doi: 10.1016/S0140-6736(08)60538-3.
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Results
Shankar AV, Asrilla Z, Kadha JK, Sebayang S, Apriatni M, Sulastri A, Sunarsih E, Shankar AH, , Programmatic effects of a large-scale multiple-micronutrient supplementation trial in Indonesia: using community facilitators as intermediaries for behavior change., Food Nutr Bull, 2009, 30, 2 Suppl, S207-14.
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Results
Allen LH, Peerson JM, , Impact of multiple micronutrient versus iron-folic acid supplements on maternal anemia and micronutrient status in pregnancy., Food Nutr Bull, 2009, 30, 4 Suppl, S527-32.
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Results
Fall CH, Fisher DJ, Osmond C, Margetts BM, , Multiple micronutrient supplementation during pregnancy in low-income countries: a meta-analysis of effects on birth size and length of gestation., Food Nutr Bull, 2009, 30, 4 Suppl, S533-46.
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Results
Ronsmans C, Fisher DJ, Osmond C, Margetts BM, Fall CH, , Multiple micronutrient supplementation during pregnancy in low-income countries: a meta-analysis of effects on stillbirths and on early and late neonatal mortality., Food Nutr Bull, 2009, 30, 4 Suppl, S547-55.
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Results
Prado EL, Hartini S, Rahmawati A, Ismayani E, Hidayati A, Hikmah N, Muadz H, Apriatni MS, Ullman MT, Shankar AH, Alcock KJ, Test selection, adaptation, and evaluation: a systematic approach to assess nutritional influences on child development in developing countries., Br J Educ Psychol, 2010, 80, Pt 1, 31-53, doi: 10.1348/000709909X470483.
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Substudy maternal mood and cognition results
Prado EL, Ullman MT, Muadz H, Alcock KJ, Shankar AH, , The effect of maternal multiple micronutrient supplementation on cognition and mood during pregnancy and postpartum in Indonesia: a randomized trial., PLoS ONE, 2012, 7, 3, e32519, doi: 10.1371/journal.pone.0032519.
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Substudy results on child cognition
Prado EL, Alcock KJ, Muadz H, Ullman MT, Shankar AH, , Maternal multiple micronutrient supplements and child cognition: a randomized trial in Indonesia., Pediatrics, 2012, 130, 3, e536-46, doi: 10.1542/peds.2012-0412.