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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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26 September 2016 |
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Main ID: |
NCT02257762 |
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Date of registration:
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02/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia
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Scientific title:
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Efficacy of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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487 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02257762 |
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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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Phase:
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N/A
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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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Bindi Borg, MA,PhD cand. |
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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 Sydney |
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Name:
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Frank T Wieringa, MD, 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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IRD |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children aged 6-12 months
- Normally nourished or only moderately malnourished (MUAC>115mm, WHZ score>-3)
- Have not received therapy for acute malnutrition within one month prior to
presentation
- Healthy (no ill-health in past two weeks)
- Anaemia status - normal, mild or moderate
- No known food intolerances
- Informed signed consent of caregiver
- Caregivers are healthy
Exclusion Criteria:
- Children <6 months or >12mths
- Severely malnourished (MUAC< 115mm, WHZ score<3, bipedal pitting oedema).
- Have received therapy for acute malnutrition within one month prior to presentation
- Any medical complications at the recruitment time or illness requiring referral or
clinic visit in past 2 weeks
- Severe anaemia (Hb<70g/l)
- Known intolerances
- No informed signed consent of caregiver
Age minimum:
6 Months
Age maximum:
12 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Child Malnutrition
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Intervention(s)
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Dietary Supplement: LNS
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Dietary Supplement: Sprinkles
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Dietary Supplement: Corn-soy blend ++ (CSB++)
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Primary Outcome(s)
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Nutritional status
[Time Frame: 6 months]
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Secondary Outcome(s)
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Iron status
[Time Frame: 6 months]
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Body composition
[Time Frame: 6 months]
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Secondary ID(s)
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LNS-CAMB-INFANTS-EFF
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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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