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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00944281
Enrollment
3220
Registered
2009-07-23
Start date
2010-05-31
Completion date
2014-12-31
Last updated
2018-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

point-of-use fortification, zinc supplement, lipid-based nutrient supplement, zinc deficiency, micronutrient deficiency, anemia

Brief summary

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.

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.

Interventions

DIETARY_SUPPLEMENTLNS-Zn5

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

DIETARY_SUPPLEMENTLNS-Zn10

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

DIETARY_SUPPLEMENTLNS-Zn0

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

DIETARY_SUPPLEMENTSuppl-Zn5

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

Sponsors

Université Polytechnique de Bobo-Dioulasso
CollaboratorOTHER
University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Months to 9 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in body composition9 to 18 mo of age
Change in length and length-for-age Z-score9 to 18 mo of age
Change in weight and weight-for-age Z-score9 to 18 mo of age
Incidence of diarrhea and laboratory-confirmed malaria infection9 to 18 mo of age
Change in plasma zinc concentration9 to 18 mo of age

Secondary

MeasureTime frame
Change in stunting, underweight, and wasting9 to 18 mo of age
Change in hemoglobin, iron, vitamin A and iodine status9 to 18 mo of age
Incidence of acute lower respiratory infection (ALRI)9 to 18 mo of age
Change in head circumference and mid-upper arm circumference9 to 18 mo of age

Countries

Burkina Faso

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026