Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

February 21, 2017 updated by: University of California, Davis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Bobo-Dioulasso, Burkina Faso
        • Institut de Recherche en Sciences de la Santé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LNS with zinc
LNS containing 10 mg zinc per 20 g dose of LNS
Dietary supplement: LNS with zinc
Lipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose
Other Names:
  • Nutriset lipid-based nutrient supplement with zinc
Placebo Comparator: LNS without zinc
LNS containing no zinc
Dietary supplement: LNS without zinc
LNS containing no zinc
Other Names:
  • Nutriset lipid-based nutrient supplement without zinc

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

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

Investigators

  • Principal Investigator: Kenneth H. Brown, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200917273
  • iLiNS-ACCEPT-Zinc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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