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

Study Overview
=================
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.

Official 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

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: LNS-Zn5
* Dietary Supplement: LNS-Zn10
* Dietary Supplement: LNS-Zn0
* Dietary Supplement: Suppl-Zn5


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 9 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LNS-Zn5<br>Daily intake of 20 g LNS containing 5 mg of zinc and a daily placebo supplement | Dietary Supplement: LNS-Zn5<br>* Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement<br>* Other names: Nutriset;|
| Experimental: LNS-Zn10<br>Daily intake of 20 g LNS containing 10 mg of zinc and a daily placebo supplement | Dietary Supplement: LNS-Zn10<br>* Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement<br>* Other names: Nutriset;|
| Placebo Comparator: LNS-Zn0<br>Daily intake of 20 g LNS containing 0 mg of zinc and a daily placebo supplement | Dietary Supplement: LNS-Zn0<br>* 20 g of LNS containing 0 mg of zinc and a daily placebo supplement<br>* Other names: Nutriset;|
| Experimental: Suppl-Zn5<br>Daily intake of zinc supplement containing 5 mg of zinc and 20 g LNS containing 0 mg of zinc | Dietary Supplement: Suppl-Zn5<br>* Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc<br>* Other names: Nutriset;|
| No Intervention: Delayed intervention group<br>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 | Measure Description | Time Frame |
| --- | --- | --- |
| Change in length and length-for-age Z-score |  | 9 to 18 mo of age | 
| Change in weight and weight-for-age Z-score |  | 9 to 18 mo of age | 
| Incidence of diarrhea and laboratory-confirmed malaria infection |  | 9 to 18 mo of age | 
| Change in plasma zinc concentration |  | 9 to 18 mo of age | 
| Change in body composition |  | 9 to 18 mo of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in head circumference and mid-upper arm circumference |  | 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 | 
| Incidence of acute lower respiratory infection (ALRI) |  | 9 to 18 mo of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
point-of-use fortification, zinc supplement, lipid-based nutrient supplement, zinc deficiency, micronutrient deficiency, anemia