Maternal and Newborn Health Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 547 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Cambodia | 4 Health Centers | Kampong Chhnang |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | International Relief and Development |
Cambodia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean birth weight | 9 months | No | |
Secondary | Mean gestational weight gain | 9 months | No | |
Secondary | Mean maternal hemoglobin level | 9 months | No | |
Secondary | Mean birth length and head circumference | 9 months | No |
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