Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

Malnutrition Clinical Trial

Official title:

Assessment of the Acceptability of Zinc-fortified Lipid Based Nutrient (LNS) Prepared for Young Burkinabe Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944814
• Other study ID #: 200917273
• Secondary ID: iLiNS-ACCEPT-Zin
• Status: Completed
• Phase: N/A
• First received: July 21, 2009
• Last updated: February 21, 2017
• Start date: July 2009
• Est. completion date: August 2009

Study information

• Verified date: February 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 15 Months

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• LNS with zinc
Lipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose
• LNS without zinc
LNS containing no zinc

Locations

Country	Name	City	State
Burkina Faso	Institut de Recherche en Sciences de la Santé	Bobo-Dioulasso

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Davis	Bill and Melinda Gates Foundation, Helen Keller International, Université Polytechnique de Bobo-Dioulasso

Country where clinical trial is conducted

Burkina Faso, 

References & Publications (1)

Hess SY, Bado L, Aaron GJ, Ouédraogo 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of each type of LNS formulation consumed by young children		3 days
Primary	Preference and detection of differences between LNS formulations among mothers		3 days
Primary	Acceptability of feeding LNS to young children at home		2 weeks