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

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: LNS-Zn5; Dietary Supplement: LNS-Zn10; Dietary Supplement: LNS-Zn0; Dietary Supplement: Suppl-Zn5

• Registration Number: NCT00944281
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Study Start: 2010-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNS-Zn5	LNS-Zn5	Daily intake of 20 g LNS containing 5 mg of zinc and a daily placebo supplement
LNS-Zn10	LNS-Zn10	Daily intake of 20 g LNS containing 10 mg of zinc and a daily placebo supplement
LNS-Zn0	LNS-Zn0	Daily intake of 20 g LNS containing 0 mg of zinc and a daily placebo supplement
Suppl-Zn5	Suppl-Zn5	Daily intake of zinc supplement containing 5 mg of zinc and 20 g LNS containing 0 mg of zinc

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut de Recherche en Sciences de la Sante; 🇧🇫 Bobo-Dioulasso, Burkina Faso