Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

Study Overview
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Brief Summary
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The purpose of the study is to assess the acceptability of the two lipid-based nutrient supplement (LNS) formulations containing no zinc and a high amount of zinc (10 mg zinc / 20 g dose of LNS). The hypothesis is that both products will be equally accepted by children and mothers.

Detailed Description
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We plan to conduct a series of acceptability studies to: 1) assess the amounts of zinc-free and high-zinc LNS consumed by children during direct observation, 2) compare their mothers' sensory assessments of the respective products, and 3) review maternal reports of their child feeding experiences during more prolonged home feeding trials.

Official Title
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Assessment of the Acceptability of Zinc-fortified Lipid Based Nutrient (LNS) Prepared for Young Burkinabe Children

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: LNS with zinc
* Dietary Supplement: LNS without zinc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently breast-feeding and consuming complementary foods for at least 30 d Exclusion Criteria: Height-for-age and weight-for height Z-scores <-3 with respect to WHO growth standards Edema Diarrhea and other diseases that could interfere with food intake Severe systemic illness History of peanut allergy History of anaphylaxis/serious allergic reaction Infants meeting these criteria and their mother's will be invited to participate

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LNS with zinc<br>LNS containing 10 mg zinc per 20 g dose of LNS | Dietary Supplement: LNS with zinc<br>* Lipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose<br>* Other names: Nutriset lipid-based nutrient supplement with zinc;|
| Placebo Comparator: LNS without zinc<br>LNS containing no zinc | Dietary Supplement: LNS without zinc<br>* LNS containing no zinc<br>* Other names: Nutriset lipid-based nutrient supplement without zinc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of each type of LNS formulation consumed by young children |  | 3 days | 
| Preference and detection of differences between LNS formulations among mothers |  | 3 days | 
| Acceptability of feeding LNS to young children at home |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipid-based nutrient supplement, Prevention of malnutrition, Prevention of micronutrient deficiencies, Zinc