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22 May 2013
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| [ Print-friendly version ] |
| 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 |
| 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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