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Supplementation with Multiple Micronutrients Intervention Trial
ISRCTN ISRCTN34151616
DOI 10.1186/ISRCTN34151616
ClinicalTrials.gov identifier
EudraCT number
Public title Supplementation with Multiple Micronutrients Intervention Trial
Scientific title
Acronym SUMMIT
Serial number at source N/A
Study hypothesis Prenatal multivitamin supplementation, in comparison to iron/folate supplements, will reduce maternal mortality, infant mortality, and improve birth weight.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Indonesia
Disease/condition/study domain Maternal and infant mortality and morbidity, and birth weight
Participants - 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.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/07/2001
Anticipated end date 30/04/2004
Status of trial Completed
Patient information material
Target number of participants 42,000
Interventions 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
Primary outcome measure(s) 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 measure(s) Current 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
Sources of funding Turner Foundation, United Nations Children's Fund (UNICEF), US Agency for International Development (USAID), Helen Keller International, Center for Health and Human Development (CHHD)
Trial website
Publications 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 substudy maternal mood and cognition results in http://www.ncbi.nlm.nih.gov/pubmed/22427850
9. 2012 substudy results on child cognition in http://www.ncbi.nlm.nih.gov/pubmed/22908103
Contact name Dr  Anuraj  Shankar
  Address Department of Nutrition
Harvard School of Public Health
665 Huntington Ave
  City/town Boston MA
  Zip/Postcode 02115
  Country United States of America
  Tel +1 617 432 4028
  Fax +1 617 432 2435
  Email ashankar@hsph.harvard.edu
Sponsor Helen Keller Int., Gov. of Indonesia, Prov. Gov. of NTB, Dis. Govs of Lombok, U of Mataram, Mataram Hospital, Johns Hopkins Univ
  Address -
  City/town Jakarta and Mataram
  Zip/Postcode -
  Country Indonesia
Date applied 29/03/2005
Last edited 03/09/2012
Date ISRCTN assigned 31/03/2005
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