Supplementation with Multiple Micronutrients Intervention Trial

ISRCTN ISRCTN34151616
DOI https://doi.org/10.1186/ISRCTN34151616
Secondary identifying numbers N/A
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleSupplementation with Multiple Micronutrients Intervention Trial
Study acronymSUMMIT
Study objectivesInitial 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) studiedMaternal and infant mortality and morbidity, and birth weight
InterventionInitial 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 typeOther
Primary outcome measure1. 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 measuresCurrent 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 study start date01/07/2001
Completion date31/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants42,000
Key inclusion criteriaPregnant 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 criteriaNot provided at time of registration
Date of first enrolment01/07/2001
Date of final enrolment30/04/2004

Locations

Countries of recruitment

  • Indonesia
  • United States of America

Study participating centre

Harvard School of Public Health
Boston
02115
United States of America

Sponsor information

Helen Keller Int., Gov. of Indonesia, Prov. Gov. of NTB, Dis. Govs of Lombok, U of Mataram, Mataram Hospital, Johns Hopkins Univ
Other

-
Jakarta and Mataram
-
Indonesia

Funders

Funder type

Other

Turner Foundation, United Nations Children's Fund (UNICEF), US Agency for International Development (USAID), Helen Keller International, Center for Health and Human Development (CHHD)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

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.