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Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944814
First Posted: July 23, 2009
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Université Polytechnique de Bobo-Dioulasso
Helen Keller International
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
University of California, Davis
  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
Malnutrition Dietary Supplement: LNS with zinc Dietary Supplement: LNS without zinc

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]
  • Preference and detection of differences between LNS formulations among mothers [ Time Frame: 3 days ]
  • Acceptability of feeding LNS to young children at home [ Time Frame: 2 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944814


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

Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00944814     History of Changes
Other Study ID Numbers: 200917273
iLiNS-ACCEPT-Zinc
First Submitted: July 21, 2009
First Posted: July 23, 2009
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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