NCT00944814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

July 21, 2009

Last Update Submit

February 21, 2017

Conditions

Malnutrition

Keywords

Lipid-based nutrient supplementPrevention of malnutritionPrevention of micronutrient deficienciesZinc

Outcome Measures

Primary Outcomes (3)

  • Amount of each type of LNS formulation consumed by young children

    3 days

  • Preference and detection of differences between LNS formulations among mothers

    3 days

  • Acceptability of feeding LNS to young children at home

    2 weeks

Study Arms (2)

LNS with zinc

EXPERIMENTAL

LNS containing 10 mg zinc per 20 g dose of LNS

Dietary Supplement: LNS with zinc

LNS without zinc

PLACEBO COMPARATOR

LNS containing no zinc

Dietary Supplement: LNS without zinc

Interventions

LNS with zincDIETARY_SUPPLEMENT

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

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

LNS containing no zinc

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

Eligibility Criteria

Age9 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche en Sciences de la Santé

Bobo-Dioulasso, Burkina Faso

Location

Related Publications (1)

  • 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.

    PMID: 21159124RESULT

MeSH Terms

Conditions

Malnutrition

Interventions

Hypoxanthine PhosphoribosyltransferaseZinc

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PentosyltransferasesGlycosyltransferasesTransferasesEnzymesEnzymes and CoenzymesMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Kenneth H. Brown, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

BU(1)