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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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 24, 2014