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Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Burkina Faso
Study Type
Interventional
Intervention
LNS with zinc
LNS without zinc
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Lipid-based nutrient supplement, Prevention of malnutrition, Prevention of micronutrient deficiencies, Zinc

Eligibility Criteria

9 Months - 15 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institut de Recherche en Sciences de la Santé

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LNS with zinc

LNS without zinc

Arm Description

LNS containing 10 mg zinc per 20 g dose of LNS

LNS containing no zinc

Outcomes

Primary Outcome Measures

Amount of each type of LNS formulation consumed by young children
Preference and detection of differences between LNS formulations among mothers
Acceptability of feeding LNS to young children at home

Secondary Outcome Measures

Full Information

First Posted
July 21, 2009
Last Updated
February 21, 2017
Sponsor
University of California, Davis
Collaborators
Université Polytechnique de Bobo-Dioulasso, Helen Keller International, Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00944814
Brief Title
Acceptability of Zinc-fortified Lipid-based Nutrient Supplements
Official Title
Assessment of the Acceptability of Zinc-fortified Lipid Based Nutrient (LNS) Prepared for Young Burkinabe Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Université Polytechnique de Bobo-Dioulasso, Helen Keller International, Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Lipid-based nutrient supplement, Prevention of malnutrition, Prevention of micronutrient deficiencies, Zinc

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LNS with zinc
Arm Type
Experimental
Arm Description
LNS containing 10 mg zinc per 20 g dose of LNS
Arm Title
LNS without zinc
Arm Type
Placebo Comparator
Arm Description
LNS containing no zinc
Intervention Type
Dietary Supplement
Intervention Name(s)
LNS with zinc
Other Intervention Name(s)
Nutriset lipid-based nutrient supplement with zinc
Intervention Description
Lipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose
Intervention Type
Dietary Supplement
Intervention Name(s)
LNS without zinc
Other Intervention Name(s)
Nutriset lipid-based nutrient supplement without zinc
Intervention Description
LNS containing no zinc
Primary Outcome Measure Information:
Title
Amount of each type of LNS formulation consumed by young children
Time Frame
3 days
Title
Preference and detection of differences between LNS formulations among mothers
Time Frame
3 days
Title
Acceptability of feeding LNS to young children at home
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth H. Brown, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Recherche en Sciences de la Santé
City
Bobo-Dioulasso
Country
Burkina Faso

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21159124
Citation
Hess SY, Bado L, Aaron GJ, Ouedraogo JB, Zeilani M, Brown KH. Acceptability of zinc-fortified, lipid-based nutrient supplements (LNS) prepared for young children in Burkina Faso. Matern Child Nutr. 2011 Oct;7(4):357-67. doi: 10.1111/j.1740-8709.2010.00287.x. Epub 2010 Dec 15.
Results Reference
result

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Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

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