Clinical trial NCT00944281: Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: point-of-use fortification
zinc supplement
lipid-based nutrient supplement
zinc deficiency
micronutrient deficiency
anemia
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Université Polytechnique de Bobo-Dioulasso
First posted: 2009-07-23
Enrollment: 3220
Sex: ALL
Minimum age (years): 9
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in length and length-for-age Z-score
timeFrame: 9 to 18 mo of age
measure: Change in weight and weight-for-age Z-score
timeFrame: 9 to 18 mo of age
measure: Incidence of diarrhea and laboratory-confirmed malaria infection
timeFrame: 9 to 18 mo of age
measure: Change in plasma zinc concentration
timeFrame: 9 to 18 mo of age
measure: Change in body composition
timeFrame: 9 to 18 mo of age
Secondary outcomes:
measure: Change in head circumference and mid-upper arm circumference
timeFrame: 9 to 18 mo of age
measure: Change in stunting, underweight, and wasting
timeFrame: 9 to 18 mo of age
measure: Change in hemoglobin, iron, vitamin A and iodine status
timeFrame: 9 to 18 mo of age
measure: Incidence of acute lower respiratory infection (ALRI)
timeFrame: 9 to 18 mo of age
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Institut de Recherche en Sciences de la Sante
Study officials:
affiliation: University of California, Davis
name: Kathryn Dewey, PhD
role: STUDY_DIRECTOR
affiliation: University of California, Davis
name: Kenneth H Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hess SY, Abbeddou S, Jimenez EY, Some JW, Vosti SA, Ouedraogo ZP, Guissou RM, Ouedraogo 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 young burkinabe children: a cluster-randomized trial. PLoS One. 2015 Mar 27;10(3):e0122242. doi: 10.1371/journal.pone.0122242. eCollection 2015.
citation: Some JW, Abbeddou S, Yakes Jimenez E, Hess SY, Ouedraogo ZP, Guissou RM, Vosti SA, Ouedraogo 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 children in rural Burkina Faso: a cluster-randomised trial. BMJ Open. 2015 Sep 11;5(9):e007828. doi: 10.1136/bmjopen-2015-007828.
citation: Hess SY, Abbeddou S, Yakes Jimenez E, Ouedraogo 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: 10.1017/S0007114515003554. Epub 2015 Sep 28.
citation: Abbeddou S, Yakes Jimenez E, Some JW, Ouedraogo 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 prevalence, but do not affect zinc status in young Burkinabe children: a cluster-randomized trial. BMC Pediatr. 2017 Feb 2;17(1):46. doi: 10.1186/s12887-016-0765-9.
citation: Hess SY, Peerson JM, Becquey E, Abbeddou S, Ouedraogo CT, Some JW, Yakes Jimenez E, Ouedraogo JB, Vosti SA, Rouamba N, Brown KH. Differing growth responses to nutritional supplements in neighboring health districts of Burkina Faso are likely due to benefits of small-quantity lipid-based nutrient supplements (LNS). PLoS One. 2017 Aug 3;12(8):e0181770. doi: 10.1371/journal.pone.0181770. eCollection 2017.
citation: Abbeddou S, Hess SY, Yakes Jimenez E, Some JW, Vosti SA, Guissou RM, Ouedraogo JB, Brown KH. Comparison of methods to assess adherence to small-quantity lipid-based nutrient supplements (SQ-LNS) and dispersible tablets among young Burkinabe children participating in a community-based intervention trial. Matern Child Nutr. 2015 Dec;11 Suppl 4(Suppl 4):90-104. doi: 10.1111/mcn.12162.
citation: Abbeddou S, Jimenez EY, Hess SY, Some JW, Ouedraogo JB, Brown KH. Small-quantity lipid-based nutrient supplements, with or without added zinc, do not cause excessive fat deposition in Burkinabe children: results from a cluster-randomized community trial. Eur J Nutr. 2022 Dec;61(8):4107-4120. doi: 10.1007/s00394-022-02936-6. Epub 2022 Jul 13.
citation: Prado EL, Abbeddou S, Adu-Afarwuah S, Arimond M, Ashorn P, Ashorn U, Brown KH, Hess SY, Lartey A, Maleta K, Ocansey E, Ouedraogo JB, Phuka J, Some JW, Vosti SA, Yakes Jimenez E, Dewey KG. Linear Growth and Child Development in Burkina Faso, Ghana, and Malawi. Pediatrics. 2016 Aug;138(2):e20154698. doi: 10.1542/peds.2015-4698.
citation: Prado EL, Abbeddou S, Yakes Jimenez E, Some JW, Ouedraogo ZP, Vosti SA, Dewey KG, Brown KH, Hess SY, Ouedraogo JB. Lipid-Based Nutrient Supplements Plus Malaria and Diarrhea Treatment Increase Infant Development Scores in a Cluster-Randomized Trial in Burkina Faso. J Nutr. 2015 Apr 1;146(4):814-822. doi: 10.3945/jn.115.225524.