Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-08-31

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.

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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.

Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LNS with zinc

LNS containing 10 mg zinc per 20 g dose of LNS

Group Type EXPERIMENTAL

LNS with zinc

Intervention Type DIETARY_SUPPLEMENT

Lipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose

LNS without zinc

LNS containing no zinc

Group Type PLACEBO_COMPARATOR

LNS without zinc

Intervention Type DIETARY_SUPPLEMENT

LNS containing no zinc

Interventions

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LNS with zinc

Lipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose

Intervention Type DIETARY_SUPPLEMENT

LNS without zinc

LNS containing no zinc

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nutriset lipid-based nutrient supplement with zinc Nutriset lipid-based nutrient supplement without zinc

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

Minimum Eligible Age

9 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes