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

This study is currently recruiting participants.
Verified February 2012 by University of British Columbia
Sponsor:
Collaborator:
International Relief and Development
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01413776
First received: August 9, 2011
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Maternal and Newborn Health
 Dietary Supplement: Corn Soya Blend+

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Mean birth weight [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: August 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413776

Contacts
Contact: Amynah Janmohamed +855 85747423 ajanmohamed@irdglobal.org

Locations
Cambodia
4 Health Centers Recruiting
Kampong Chhnang, Cambodia
Contact: Somchit Boungnasiri     +855 17848726        
Sponsors and Collaborators
University of British Columbia
International Relief and Development
Investigators
Principal Investigator: Judy McLean, Dr. University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01413776     History of Changes
Other Study ID Numbers: H11-00801
Study First Received: August 9, 2011
Last Updated: February 29, 2012
Health Authority: Canada: Health Canada
Cambodia: Ministry of Health

ClinicalTrials.gov processed this record on May 16, 2013