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

Maternal and Newborn Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413776
• Other study ID #: H11-00801
• Status: Completed
• Phase: N/A
• First received: August 9, 2011
• Last updated: March 14, 2014
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCambodia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Maternal and Newborn Health

Intervention

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.

Locations

Country	Name	City	State
Cambodia	4 Health Centers	Kampong Chhnang

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	International Relief and Development

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean birth weight		9 months	No
Secondary	Mean gestational weight gain		9 months	No
Secondary	Mean maternal hemoglobin level		9 months	No
Secondary	Mean birth length and head circumference		9 months	No