NCT00944853

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2010

Enrollment Period

4 months

First QC Date

July 21, 2009

Last Update Submit

February 22, 2017

Conditions

Zinc Deficiency

Keywords

zinc supplementpreventionzinc deficiencyplasma zinc concentration

Outcome Measures

Primary Outcomes (1)

  • Plasma zinc concentration

    3 weeks

Study Arms (3)

Zinc syrup

EXPERIMENTAL

Liquid Zinc Syrup (ZnSO4) solution provided daily

Dietary Supplement: Liquid zinc syrup

Zinc tablet

EXPERIMENTAL

Dispersible zinc tablets provided daily

Dietary Supplement: Zinc tablet

Placebo

PLACEBO COMPARATOR

Liquid placebo supplement provided daily

Dietary Supplement: Liquid placebo supplement

Interventions

Liquid zinc syrupDIETARY_SUPPLEMENT

Liquid zinc syrup containing 5 mg zinc as zinc sulfate

Also known as: Phytofla, Banfora, Burkina Faso
Zinc syrup
Zinc tabletDIETARY_SUPPLEMENT

Dispersible zinc tablet containing 5 mg zinc

Also known as: Nutriset S.A.S., France
Zinc tablet
Liquid placebo supplementDIETARY_SUPPLEMENT

Liquid placebo supplement containing 0 mg zinc

Also known as: Phytofla, Banfora, Burkina Faso
Placebo

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toussiana Health District

Touziana, Burkina Faso

Location

Related Publications (4)

  • 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.

    PMID: 21871635RESULT

  • 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.

    PMID: 30976780DERIVED

  • 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.

    PMID: 25411038DERIVED

  • 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.

    PMID: 23689263DERIVED

MeSH Terms

Interventions

Zinc

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Kenneth H Brown, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

February 24, 2017

Record last verified: 2010-02

Locations

BU(1)