Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS)

July 11, 2018 updated by: University of California, Davis

A Randomized, Double-blind, Controlled Trial in Rural Burkina Faso to Determine the Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS). Part of the iLiNS Study

To assess zinc-related biochemical and functional responses among young Burkinabe children with a presumed high risk of zinc deficiency who receive micronutrient products containing different amounts of zinc, provided with or between meals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Young healthy children will be identified by periodic consensus in the study area. 3200 infants meeting a set of eligibility criteria will be randomly assigned to receive lipid-based nutrient supplements (LNS) with different amounts of zinc and a placebo or zinc supplement from 9 to 18 months of age. The families will receive the respective supplement at weekly intervals and the participants undergo a morbidity evaluation weekly, anthropometric evaluation at 9, 12, 15 and 18 months and laboratory analyses at enrollment and at 18 months of age. Growth outcomes will be analyzed during the two-year follow up at 24, 30, 36 and 42 months of age.

Study Type

Interventional

Enrollment (Actual)

3220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 9 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 9.0 to 9.9 mo of age

Exclusion Criteria:

  • severe anemia
  • severely malnourished
  • presence of bipedal oedema
  • severe illness
  • congenital abnormalities
  • chronic medical condition
  • known HIV infection of mother or infant
  • history of peanut allergy
  • history of anaphylaxis or serious allergic reaction to any substance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LNS-Zn5
Daily intake of 20 g LNS containing 5 mg of zinc and a daily placebo supplement
Dietary supplement: LNS-Zn5
Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement
Other Names:
  • Nutriset
Experimental: LNS-Zn10
Daily intake of 20 g LNS containing 10 mg of zinc and a daily placebo supplement
Dietary supplement: LNS-Zn10
Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement
Other Names:
  • Nutriset
Placebo Comparator: LNS-Zn0
Daily intake of 20 g LNS containing 0 mg of zinc and a daily placebo supplement
Dietary supplement: LNS-Zn0
20 g of LNS containing 0 mg of zinc and a daily placebo supplement
Other Names:
  • Nutriset
Experimental: Suppl-Zn5
Daily intake of zinc supplement containing 5 mg of zinc and 20 g LNS containing 0 mg of zinc
Dietary supplement: Suppl-Zn5
Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc
Other Names:
  • Nutriset
No Intervention: Delayed intervention group
Standard care from age 8 to 18 months. Daily consumption of LNS from age 18 to 28 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in length and length-for-age Z-score
Time Frame: 9 to 18 mo of age
9 to 18 mo of age
Change in weight and weight-for-age Z-score
Time Frame: 9 to 18 mo of age
9 to 18 mo of age
Incidence of diarrhea and laboratory-confirmed malaria infection
Time Frame: 9 to 18 mo of age
9 to 18 mo of age
Change in plasma zinc concentration
Time Frame: 9 to 18 mo of age
9 to 18 mo of age
Change in body composition
Time Frame: 9 to 18 mo of age
9 to 18 mo of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in head circumference and mid-upper arm circumference
Time Frame: 9 to 18 mo of age
9 to 18 mo of age
Change in stunting, underweight, and wasting
Time Frame: 9 to 18 mo of age
9 to 18 mo of age
Change in hemoglobin, iron, vitamin A and iodine status
Time Frame: 9 to 18 mo of age
9 to 18 mo of age
Incidence of acute lower respiratory infection (ALRI)
Time Frame: 9 to 18 mo of age
9 to 18 mo of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Université Polytechnique de Bobo-Dioulasso

Investigators

  • Study Director: Kathryn Dewey, PhD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Actual)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 236850
  • iLiNS-Zinc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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