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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:
ClinicalTrials.gov Identifier:
NCT01413776
First Posted: August 10, 2011
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
International Relief and Development
Information provided by (Responsible Party):
University of British Columbia
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Mean gestational weight gain [ Time Frame: 9 months ]
  • Mean maternal hemoglobin level [ Time Frame: 9 months ]
  • Mean birth length and head circumference [ Time Frame: 9 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01413776     History of Changes
Other Study ID Numbers: H11-00801
First Submitted: August 9, 2011
First Posted: August 10, 2011
Last Update Posted: March 17, 2014
Last Verified: March 2014