Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia|
- Mean birth weight [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Mean gestational weight gain [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Mean maternal hemoglobin level [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Mean birth length and head circumference [ Time Frame: 9 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Dietary supplement
Pregnant women in 37 villages.
Dietary Supplement: Corn Soya Blend+
A blended food consisting of corn (75-80%) and soybeans (20-25%) that has been fortified with a premix of 19 vitamins and minerals.
No Intervention: Control group
Pregnant women in 38 villages
|4 Health Centers|
|Kampong Chhnang, Cambodia|
|Principal Investigator:||Judy McLean, Dr.||University of British Columbia|