Effects of Liquid Zinc Supplementation and Dispersible Zinc Tablets on Plasma Zinc Concentration

University of California (UC) Davis

Status: Completed

Conditions: Zinc Deficiency

Treatments: Dietary Supplement: Zinc tablet; Dietary Supplement: Liquid zinc syrup; Dietary Supplement: Liquid placebo supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00944853

ZincTab

200917272

Details and patient eligibility

About

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

Full 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.

Enrollment: 462 patients

Sex: All

Ages: 6 to 23 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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462 participants in 3 patient groups, including a placebo group

Zinc syrup

Experimental group

Description:

Liquid Zinc Syrup (ZnSO4) solution provided daily

Treatment:

Dietary Supplement: Liquid zinc syrup

Zinc tablet

Experimental group

Description:

Dispersible zinc tablets provided daily

Treatment:

Dietary Supplement: Zinc tablet

Placebo

Placebo Comparator group

Description:

Liquid placebo supplement provided daily

Treatment:

Dietary Supplement: Liquid placebo supplement