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Main
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Note: This record shows only 22 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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18 January 2016 |
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Main ID: |
NCT02294240 |
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Date of registration:
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05/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Energy Dense Biscuits in Undernourished Women on Birth Weight of Their Neonates
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Scientific title:
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Effect of Energy Dense Biscuits in Under Nourished Pregnant Women on Birth Weight of Their Newborns in a Low Income Peri-urban Setting of Karachi; a Community Based Randomized Interventional Study |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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224 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02294240 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Farah N Qamar |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aga Khan University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
All pregnant females with gestational age =14 weeks and Body mass index(BMI) <18.5
Exclusion Criteria:
Pregnant females with underlying chronic illness (cardiovascular disease, diabetes, renal
disease, and hypertension)
Pregnant females with history of multiple abortions ( two or more abortions)
Pregnant females identified as having twin/triplet pregnancies
Pregnant females not consenting to participate
Pregnant females who are already enrolled in any other study that may interfere with the
results of this study
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Birth Weight
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Intervention(s)
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Other: Wheat Flour, oil, iron & Folic acid
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Dietary Supplement: Energy dense biscuits
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Primary Outcome(s)
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Neonatal birth weight
[Time Frame: within 48 hours of birth]
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Secondary Outcome(s)
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Maternal Hemoglobin and Ferritin
[Time Frame: On enrollment and last visit (33-35 weeks of gestation)]
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Maternal weight gain
[Time Frame: on enrolment,20-22 week, 33-35 week of gestation]
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Palatability, acceptability, and compliance of the biscuits
[Time Frame: On last visit (33-35 weeks of gestation)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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