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OpenTrials
Completed

NCT Number: NCT01413776

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

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.

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Key information

Conditions

Maternal and Newborn Health

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

4 Health Centers

Kampong Chhnang, Cambodia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corn Soya Blend+

Dietary Supplement

A blended food consisting of corn (75-80%) and soybeans (20-25%) that has been fortified with a premix of 19 vitamins and minerals.

Primary outcomes

  1. Mean birth weight

    Time frame: 9 months

Secondary outcomes

  1. Mean gestational weight gain

    Time frame: 9 months

  2. Mean maternal hemoglobin level

    Time frame: 9 months

  3. Mean birth length and head circumference

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • International Relief and Development

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 10, 2011
Registry last updated
Mar 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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