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Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

This study has been completed.
Sponsor:
Collaborators:
Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso
Helen Keller International
Bill and Melinda Gates Foundation
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00944814
First received: July 21, 2009
Last updated: February 18, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Malnutrition
 Dietary Supplement: LNS with zinc
Dietary Supplement: LNS without zinc
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of the Acceptability of Zinc-fortified Lipid Based Nutrient (LNS) Prepared for Young Burkinabe Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Amount of each type of LNS formulation consumed by young children [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Preference and detection of differences between LNS formulations among mothers [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Acceptability of feeding LNS to young children at home [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Nutriset lipid-based nutrient supplement without zinc

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.

  Eligibility

Ages Eligible for Study:   9 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944814

Locations
Burkina Faso
Institut de Recherche en Sciences de la Santé
Bobo-Dioulasso, Burkina Faso
Sponsors and Collaborators
University of California, Davis
Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso
Helen Keller International
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Kenneth H. Brown, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Prof. Kenneth H. Brown, University of California Davis
ClinicalTrials.gov Identifier: NCT00944814     History of Changes
Other Study ID Numbers: 200917273, iLiNS-ACCEPT-Zinc
Study First Received: July 21, 2009
Last Updated: February 18, 2010
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by University of California, Davis:
Lipid-based nutrient supplement
Prevention of malnutrition
Prevention of micronutrient deficiencies
Zinc

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Zinc
Trace Elements
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013