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

This study has been completed.
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: March 14, 2014
Last verified: March 2014
  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:


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 ]

Enrollment: 547
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (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

Locations
Cambodia
4 Health Centers
Kampong Chhnang, Cambodia
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: March 14, 2014
Health Authority: Canada: Health Canada
Cambodia: Ministry of Health

ClinicalTrials.gov processed this record on April 17, 2014