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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01413776 |
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Date of registration:
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09/08/2011 |
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Primary sponsor: |
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Public title:
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Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
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Scientific title:
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Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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600 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01413776 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Cambodia
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Contacts
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Name:
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Somchit Boungnasiri |
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Address:
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Telephone:
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+855 17848726 |
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Email:
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Affiliation:
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Name:
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Amynah Janmohamed |
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Address:
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Telephone:
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+855 85747423 |
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Email:
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ajanmohamed@irdglobal.org |
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Affiliation:
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Name:
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Judy McLean, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Maternal and Newborn Health
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Intervention(s)
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Dietary Supplement: Corn Soya Blend+
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Primary Outcome(s)
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Mean birth weight
[Time Frame: 9 months]
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Secondary Outcome(s)
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Mean birth length and head circumference
[Time Frame: 9 months]
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Mean gestational weight gain
[Time Frame: 9 months]
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Mean maternal hemoglobin level
[Time Frame: 9 months]
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Secondary ID(s)
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H11-00801
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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