Skip to main content
OpenTrials
Completed

NCT Number: NCT00944281

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malnutrition Anemia Hematologic Diseases Hemic and Lymphatic Diseases Nutrition Disorders Nutritional and Metabolic Diseases

Age range

9 month–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherche en Sciences de la Sante

Bobo-Dioulasso, Burkina Faso

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LNS-Zn5

Dietary Supplement

Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement

Other names: Nutriset

LNS-Zn10

Dietary Supplement

Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement

Other names: Nutriset

LNS-Zn0

Dietary Supplement

20 g of LNS containing 0 mg of zinc and a daily placebo supplement

Other names: Nutriset

Suppl-Zn5

Dietary Supplement

Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc

Other names: Nutriset

Primary outcomes

  1. Change in length and length-for-age Z-score

    Time frame: 9 to 18 mo of age

  2. Change in weight and weight-for-age Z-score

    Time frame: 9 to 18 mo of age

  3. Incidence of diarrhea and laboratory-confirmed malaria infection

    Time frame: 9 to 18 mo of age

  4. Change in plasma zinc concentration

    Time frame: 9 to 18 mo of age

  5. Change in body composition

    Time frame: 9 to 18 mo of age

Secondary outcomes

  1. Change in head circumference and mid-upper arm circumference

    Time frame: 9 to 18 mo of age

  2. Change in stunting, underweight, and wasting

    Time frame: 9 to 18 mo of age

  3. Change in hemoglobin, iron, vitamin A and iodine status

    Time frame: 9 to 18 mo of age

  4. Incidence of acute lower respiratory infection (ALRI)

    Time frame: 9 to 18 mo of age

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Université Polytechnique de Bobo-Dioulasso

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 23, 2009
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.