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Completed

NCT Number: NCT00944814

Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

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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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

9 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherche en Sciences de la Santé

Bobo-Dioulasso, Burkina Faso

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LNS with zinc

Dietary Supplement

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

Other names: Nutriset lipid-based nutrient supplement with zinc

LNS without zinc

Dietary Supplement

LNS containing no zinc

Other names: Nutriset lipid-based nutrient supplement without zinc

Primary outcomes

  1. Amount of each type of LNS formulation consumed by young children

    Time frame: 3 days

  2. Preference and detection of differences between LNS formulations among mothers

    Time frame: 3 days

  3. Acceptability of feeding LNS to young children at home

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Helen Keller International
  • Université Polytechnique de Bobo-Dioulasso

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 23, 2009
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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