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Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

University of California (UC) Davis logo

University of California (UC) Davis

Status

Completed

Conditions

Malnutrition

Treatments

Dietary Supplement: LNS without zinc
Dietary Supplement: LNS with zinc

Study type

Interventional

Funder types

Other

Identifiers

NCT00944814
iLiNS-ACCEPT-Zinc
200917273

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

9 to 15 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

36 participants in 2 patient groups, including a placebo group

LNS with zinc
Experimental group
Description:
LNS containing 10 mg zinc per 20 g dose of LNS
Treatment:
Dietary Supplement: LNS with zinc
LNS without zinc
Placebo Comparator group
Description:
LNS containing no zinc
Treatment:
Dietary Supplement: LNS without zinc

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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