Supplementation with Multiple Micronutrients Intervention Trial

ISRCTN	ISRCTN34151616
DOI	https://doi.org/10.1186/ISRCTN34151616
Protocol serial number	N/A
Sponsor	Helen Keller Int., Gov. of Indonesia, Prov. Gov. of NTB, Dis. Govs of Lombok, U of Mataram, Mataram Hospital, Johns Hopkins Univ
Funder	Turner Foundation, United Nations Children's Fund (UNICEF), US Agency for International Development (USAID), Helen Keller International, Center for Health and Human Development (CHHD)

Submission date: 29/03/2005
Registration date: 31/03/2005
Last edited: 11/06/2019

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

Dr Anuraj Shankar
Scientific

Department of Nutrition
Harvard School of Public Health
665 Huntington Ave
Boston MA
02115
United States of America

Phone	+1 617 432 4028
Email	ashankar@hsph.harvard.edu

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Supplementation with Multiple Micronutrients Intervention Trial
Study acronym	SUMMIT
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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
Key secondary outcome measure(s)	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
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	42000
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/07/2001
Date of final enrolment	30/04/2004

Locations

Countries of recruitment

Indonesia
United States of America

Study participating centre

Harvard School of Public Health

Boston
02115
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/01/2008		Yes	No
Results article	results	12/04/2008		Yes	No
Results article	results	01/06/2009		Yes	No
Results article	results	01/12/2009		Yes	No
Results article	results	01/12/2009		Yes	No
Results article	results	01/12/2009		Yes	No
Results article	results	01/03/2010		Yes	No
Results article	results	01/10/2011		Yes	No
Results article	results	01/08/2012		Yes	No
Results article	substudy results on child cognition	01/09/2012		Yes	No
Results article	substudy maternal mood and cognition results	01/10/2012		Yes	No
Results article	results	01/02/2017		Yes	No
Results article	results	01/08/2019	11/06/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/06/2019: Publication reference added.

23/01/2017: Publication reference added.

03/12/2015: The study record has been updated to include the methodology and hypothesis of a 10-year follow up study, conducted between early 2012 and December 14. The outcome measures have additionally been updated and further publication records have been added.