Clinical trial NCT00944853: Effects of Liquid Zinc Supplementation and Dispersible Zinc Tablets on Plasma Zinc Concentration
Official title: The Effect of Zinc Supplementation, Provided as Either a Liquid Zinc Solution or Dispersible Tablets, on Plasma Zinc Concentration Among Young Burkinabe Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zinc Deficiency
Keywords: zinc supplement
prevention
zinc deficiency
plasma zinc concentration
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Université Polytechnique de Bobo-Dioulasso
name: Helen Keller International
name: Nutriset
First posted: 2009-07-23
Enrollment: 462
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to compare the effects of two different formulations of zinc supplements on plasma zinc concentrations among young Burkinabe children.

Detailed description: 1) To investigate the effects of short-term zinc supplementation, provided either as a dispersible tablet containing zinc sulfate ("ZinCfant," Nutriset Ltd; Malaunay, France) or as a liquid ZnSO4 solution, on changes in serum zinc concentration, compared with a placebo in young Burkinabe children; and 2) to assess the relationship between change in serum zinc concentration and the presence of altered intestinal permeability within each treatment group.

Eligibility criteria: Inclusion Criteria:

* currently breast feeding
* informed consent of a parent or guardian.

Exclusion Criteria:

* symptomatic acute or chronic febrile infections
* diarrhea within the past week
* consuming vitamin or mineral supplements or zinc-fortified infant formulas

Primary outcomes:
measure: Plasma zinc concentration
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toussiana
country: Burkina Faso
facility: Toussiana Health District
Study officials:
affiliation: University of California, Davis
name: Kenneth H Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wessells KR, Ouedraogo ZP, Rouamba N, Hess SY, Ouedraogo JB, Brown KH. Short-term zinc supplementation with dispersible tablets or zinc sulfate solution yields similar positive effects on plasma zinc concentration of young children in Burkina Faso: a randomized controlled trial. J Pediatr. 2012 Jan;160(1):129-35.e3. doi: 10.1016/j.jpeds.2011.06.051. Epub 2011 Aug 25.
citation: Wessells KR, Peerson JM, Brown KH. Within-individual differences in plasma ferritin, retinol-binding protein, and zinc concentrations in relation to inflammation observed during a short-term longitudinal study are similar to between-individual differences observed cross-sectionally. Am J Clin Nutr. 2019 May 1;109(5):1484-1492. doi: 10.1093/ajcn/nqz014.
citation: Wessells KR, Hess SY, Ouedraogo ZP, Rouamba N, Ouedraogo JB, Brown KH. Asymptomatic malaria infection affects the interpretation of biomarkers of iron and vitamin A status, even after adjusting for systemic inflammation, but does not affect plasma zinc concentrations among young children in Burkina Faso. J Nutr. 2014 Dec;144(12):2050-8. doi: 10.3945/jn.114.200345. Epub 2014 Oct 1.
citation: Wessells KR, Hess SY, Rouamba N, Ouedraogo ZP, Kellogg M, Goto R, Duggan C, Ouedraogo JB, Brown KH. Associations between intestinal mucosal function and changes in plasma zinc concentration following zinc supplementation. J Pediatr Gastroenterol Nutr. 2013 Sep;57(3):348-55. doi: 10.1097/MPG.0b013e31829b4e9e.