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CompletedNCT00944814Updated Feb 23, 2017

Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

An interventional study of LNS with zinc and LNS without zinc in Malnutrition, sponsored by University of California, Davis. Completed at 1 site in Burkina Faso. Open to participants aged 9 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by University of California, Davis · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
9 Months to 15 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malnutrition

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Keywords

  • Lipid-based nutrient supplement
  • Prevention of malnutrition
  • Prevention of micronutrient deficiencies
  • Zinc
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 36 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Currently breast-feeding and consuming complementary foods for at least 30 d

Exclusion criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    LNS with zinc

    LNS containing 10 mg zinc per 20 g dose of LNS

    Dietary Supplement: LNS with zinc

  • Placebo comparator
    LNS without zinc

    LNS containing no zinc

    Dietary Supplement: LNS without zinc

Interventions

  • Dietary supplementLNS with zinc

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

    Also known as: Nutriset lipid-based nutrient supplement with zinc

  • Dietary supplementLNS without zinc

    LNS containing no zinc

    Also known as: Nutriset lipid-based nutrient supplement without zinc

06

What researchers measure

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

07

Study locations

1 site
  • Institut de Recherche en Sciences de la Santé
    Bobo-Dioulasso, Burkina Faso
08

References and documents

Publications

  • 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. PubMed 21159124 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00944814
Lead sponsor
University of California, Davis
Collaborators
Université Polytechnique de Bobo-Dioulasso, Helen Keller International, Bill and Melinda Gates Foundation
Responsible party
Sponsor
First posted
Jul 23, 2009
Start date
Jul 2009
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Feb 23, 2017

Study contacts

Kenneth H. Brown, MD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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