Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia

Not Applicable

Completed

• Conditions: Maternal and Newborn Health
• Interventions: Dietary Supplement: Corn Soya Blend+

• Registration Number: NCT01413776
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 547

Inclusion Criteria

• at least 18 years of age
• in first trimester of pregnancy
• plans to reside in the same village during the entire pregnancy

Exclusion Criteria

• a minor
• not in first trimester of pregnancy
• plans to relocate during the pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary supplement	Corn Soya Blend+	Pregnant women in 37 villages.

Primary Outcome Measures

Name	Time	Method
Mean birth weight	9 months

Secondary Outcome Measures

Name	Time	Method
Mean gestational weight gain	9 months
Mean maternal hemoglobin level	9 months
Mean birth length and head circumference	9 months

Trial Locations

Locations (1)

4 Health Centers; 🇰🇭 Kampong Chhnang, Cambodia