Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
1 other identifier
interventional
547
1 country
1
Brief Summary
The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 17, 2014
March 1, 2014
1.6 years
August 9, 2011
March 14, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Mean birth weight
9 months
Secondary Outcomes (3)
Mean gestational weight gain
9 months
Mean maternal hemoglobin level
9 months
Mean birth length and head circumference
9 months
Study Arms (2)
Dietary supplement
EXPERIMENTALPregnant women in 37 villages.
Control group
NO INTERVENTIONPregnant women in 38 villages
Interventions
A blended food consisting of corn (75-80%) and soybeans (20-25%) that has been fortified with a premix of 19 vitamins and minerals.
Eligibility Criteria
You may qualify if:
- at least 18 years of age
- in first trimester of pregnancy
- plans to reside in the same village during the entire pregnancy
You may not qualify if:
- a minor
- not in first trimester of pregnancy
- plans to relocate during the pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
4 Health Centers
Kampong Chhnang, Cambodia
Related Publications (2)
Janmohamed A, Karakochuk CD, Boungnasiri S, Chapman GE, Janssen PA, Brant R, Green TJ, McLean J. Prenatal supplementation with Corn Soya Blend Plus reduces the risk of maternal anemia in late gestation and lowers the rate of preterm birth but does not significantly improve maternal weight gain and birth anthropometric measurements in rural Cambodian women: a randomized trial. Am J Clin Nutr. 2016 Feb;103(2):559-66. doi: 10.3945/ajcn.114.104034. Epub 2016 Jan 6.
PMID: 26739037DERIVEDJanmohamed A, Karakochuk CD, Boungnasiri S, Whitfield KC, Chapman GE, Janssen P, McLean J, Green TJ. Factors affecting the acceptability and consumption of Corn Soya Blend Plus as a prenatal dietary supplement among pregnant women in rural Cambodia. Public Health Nutr. 2016 Jul;19(10):1842-51. doi: 10.1017/S1368980015003018. Epub 2015 Oct 16.
PMID: 26471409DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Judy McLean, Dr.
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 10, 2011
Study Start
August 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
March 17, 2014
Record last verified: 2014-03