Condition category
Pregnancy and Childbirth
Date applied
29/03/2005
Date assigned
31/03/2005
Last edited
03/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anuraj Shankar

ORCID ID

Contact details

Department of Nutrition
Harvard School of Public Health
665 Huntington Ave
Boston MA
02115
United States of America
+1 617 432 4028
ashankar@hsph.harvard.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SUMMIT

Study hypothesis

Prenatal multivitamin supplementation, in comparison to iron/folate supplements, will reduce maternal mortality, infant mortality, and improve birth weight.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Maternal and infant mortality and morbidity, and birth weight

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 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 trial start date

01/07/2001

Overall trial end date

30/04/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

42,000

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2001

Recruitment end date

30/04/2004

Locations

Countries of recruitment

Indonesia

Trial participating centre

Department of Nutrition
Boston MA
02115
United States of America

Sponsor information

Organisation

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

Sponsor details

-
Jakarta and Mataram
-
Indonesia

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    , Shankar AH, Jahari AB, Sebayang SK, Aditiawarman, Apriatni M, Harefa B, Muadz H, Soesbandoro SD, Tjiong R, Fachry A, Shankar AV, Atmarita, Prihatini S, Sofia G, Effect of maternal multiple micronutrient supplementation on fetal loss and infant death in Indonesia: a double-blind cluster-randomised trial., Lancet, 2008, 371, 9608, 215-227, doi: 10.1016/S0140-6736(08)60133-6.

  2. Results

    Shankar A, Sebayang S, Guarenti L, Utomo B, Islam M, Fauveau V, Jalal F, The village-based midwife programme in Indonesia., Lancet, 2008, 371, 9620, 1226-1229, doi: 10.1016/S0140-6736(08)60538-3.

  3. Results

    Shankar AV, Asrilla Z, Kadha JK, Sebayang S, Apriatni M, Sulastri A, Sunarsih E, Shankar AH, , Programmatic effects of a large-scale multiple-micronutrient supplementation trial in Indonesia: using community facilitators as intermediaries for behavior change., Food Nutr Bull, 2009, 30, 2 Suppl, S207-14.

  4. Results

    Allen LH, Peerson JM, , Impact of multiple micronutrient versus iron-folic acid supplements on maternal anemia and micronutrient status in pregnancy., Food Nutr Bull, 2009, 30, 4 Suppl, S527-32.

  5. Results

    Fall CH, Fisher DJ, Osmond C, Margetts BM, , Multiple micronutrient supplementation during pregnancy in low-income countries: a meta-analysis of effects on birth size and length of gestation., Food Nutr Bull, 2009, 30, 4 Suppl, S533-46.

  6. Results

    Ronsmans C, Fisher DJ, Osmond C, Margetts BM, Fall CH, , Multiple micronutrient supplementation during pregnancy in low-income countries: a meta-analysis of effects on stillbirths and on early and late neonatal mortality., Food Nutr Bull, 2009, 30, 4 Suppl, S547-55.

  7. Results

    Prado EL, Hartini S, Rahmawati A, Ismayani E, Hidayati A, Hikmah N, Muadz H, Apriatni MS, Ullman MT, Shankar AH, Alcock KJ, Test selection, adaptation, and evaluation: a systematic approach to assess nutritional influences on child development in developing countries., Br J Educ Psychol, 2010, 80, Pt 1, 31-53, doi: 10.1348/000709909X470483.

  8. Substudy maternal mood and cognition results

    Prado EL, Ullman MT, Muadz H, Alcock KJ, Shankar AH, , The effect of maternal multiple micronutrient supplementation on cognition and mood during pregnancy and postpartum in Indonesia: a randomized trial., PLoS ONE, 2012, 7, 3, e32519, doi: 10.1371/journal.pone.0032519.

  9. Substudy results on child cognition

    Prado EL, Alcock KJ, Muadz H, Ullman MT, Shankar AH, , Maternal multiple micronutrient supplements and child cognition: a randomized trial in Indonesia., Pediatrics, 2012, 130, 3, e536-46, doi: 10.1542/peds.2012-0412.

Additional files

Editorial Notes