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

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944281
• Other study ID #: 236850
• Secondary ID: iLiNS-Zinc
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: December 2014

Study information

• Verified date: July 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3220
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 9 Months

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• LNS-Zn5
Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement
• LNS-Zn10
Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement
• LNS-Zn0
20 g of LNS containing 0 mg of zinc and a daily placebo supplement
• Suppl-Zn5
Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc

Locations

Country	Name	City	State
Burkina Faso	Institut de Recherche en Sciences de la Sante	Bobo-Dioulasso

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Université Polytechnique de Bobo-Dioulasso

Country where clinical trial is conducted

Burkina Faso, 

References & Publications (6)

Abbeddou S, Hess SY, Yakes Jimenez E, Somé JW, Vosti SA, Guissou RM, Ouédraogo JB, Brown KH. Comparison of methods to assess adherence to small-quantity lipid-based nutrient supplements (SQ-LNS) and dispersible tablets among young Burkinabé children parti — View Citation

Abbeddou S, Yakes Jimenez E, Somé JW, Ouédraogo JB, Brown KH, Hess SY. Small-quantity lipid-based nutrient supplements containing different amounts of zinc along with diarrhea and malaria treatment increase iron and vitamin A status and reduce anemia prev — View Citation

Hess SY, Abbeddou S, Jimenez EY, Somé JW, Vosti SA, Ouédraogo ZP, Guissou RM, Ouédraogo JB, Brown KH. Small-quantity lipid-based nutrient supplements, regardless of their zinc content, increase growth and reduce the prevalence of stunting and wasting in y — View Citation

Hess SY, Abbeddou S, Yakes Jimenez E, Ouédraogo JB, Brown KH. Iodine status of young Burkinabe children receiving small-quantity lipid-based nutrient supplements and iodised salt: a cluster-randomised trial. Br J Nutr. 2015 Dec 14;114(11):1829-37. doi: 10 — View Citation

Hess SY, Peerson JM, Becquey E, Abbeddou S, Ouédraogo CT, Somé JW, Yakes Jimenez E, Ouédraogo JB, Vosti SA, Rouamba N, Brown KH. Differing growth responses to nutritional supplements in neighboring health districts of Burkina Faso are likely due to benefi — View Citation

Somé JW, Abbeddou S, Yakes Jimenez E, Hess SY, Ouédraogo ZP, Guissou RM, Vosti SA, Ouédraogo JB, Brown KH. Effect of zinc added to a daily small-quantity lipid-based nutrient supplement on diarrhoea, malaria, fever and respiratory infections in young chil — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in length and length-for-age Z-score		9 to 18 mo of age
Primary	Change in weight and weight-for-age Z-score		9 to 18 mo of age
Primary	Incidence of diarrhea and laboratory-confirmed malaria infection		9 to 18 mo of age
Primary	Change in plasma zinc concentration		9 to 18 mo of age
Primary	Change in body composition		9 to 18 mo of age
Secondary	Change in head circumference and mid-upper arm circumference		9 to 18 mo of age
Secondary	Change in stunting, underweight, and wasting		9 to 18 mo of age
Secondary	Change in hemoglobin, iron, vitamin A and iodine status		9 to 18 mo of age
Secondary	Incidence of acute lower respiratory infection (ALRI)		9 to 18 mo of age

External Links

•   PLoS ONE: Small-quantity lipid-based nutrient supplements...