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
Scientific
Department of Nutrition
Harvard School of Public Health
665 Huntington Ave
Boston MA
02115
United States of America
| Phone | +1 617 432 4028 |
|---|---|
| ashankar@hsph.harvard.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | 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 study start date | 01/07/2001 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 42,000 |
| 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
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
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
