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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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21 November 2016 |
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Main ID: |
NCT02120599 |
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Date of registration:
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18/04/2014 |
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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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Interventions for Moderate Malnutrition in Pregnancy
Mamachiponde |
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Scientific title:
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Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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1867 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02120599 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), 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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Malawi
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Contacts
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Name:
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Peggy C Papathakis, PhD, RD |
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Address:
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Telephone:
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Email:
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Affiliation:
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California Polytechnic State University-San Luis Obispo |
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Name:
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Mark J Manary, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University in St. Louis; University of Malawi |
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Name:
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Chrissie Thakwalakwa |
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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 Malawi |
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Name:
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Kenneth Maleta, MBBS PhD |
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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 Malawi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant and consenting to study participation and HIV testing (if not already
performed)
- mid-upper-arm circumference (MUAC) = 23 cm
- planning to stay in the area and attend the clinic during pregnancy and for 3 months
post partum
Exclusion Criteria:
- Pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
- Severe anemia (Hg <7.0 mg/dl)
- Severe malnutrition
- under 18 years of age
- over estimated 35 weeks of gestation
Age minimum:
14 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Moderate Malnutrition
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Pregnancy
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Intervention(s)
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Dietary Supplement: corn-soy blend
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Dietary Supplement: folic acid
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Dietary Supplement: ready-to-use supplementary food
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Dietary Supplement: iron
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Dietary Supplement: UNIMMAP
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Primary Outcome(s)
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infant birth length
[Time Frame: up to 40 weeks]
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infant birth weight
[Time Frame: up to 40 weeks]
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premature delivery
[Time Frame: up to 36 weeks]
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Maternal change in mid-upper arm circumference (MUAC)
[Time Frame: up to 40 weeks]
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Proportion recovered from moderate acute malnutrition (MAM)
[Time Frame: up to 40 weeks]
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Secondary Outcome(s)
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infant weight at 3 months
[Time Frame: 3 months]
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maternal weight gain
[Time Frame: up to 40 weeks]
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pregnancy complications
[Time Frame: up to 40 weeks]
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infant length at 3 months
[Time Frame: 3 months]
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maternal hemoglobin
[Time Frame: 8 weeks]
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infant survival at 3 months
[Time Frame: 3 months]
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Secondary ID(s)
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201401112
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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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