NCT00944398

Brief Summary

The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of targeted zinc fortification programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

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
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 19, 2010

Status Verified

February 1, 2010

Enrollment Period

8 months

First QC Date

July 21, 2009

Last Update Submit

February 18, 2010

Conditions

Zinc Deficiency

Keywords

Zinc fortificationPlasma zinc concentrationAssessment of zinc status

Outcome Measures

Primary Outcomes (1)

  • Plasma zinc concentration

    3 weeks

Study Arms (3)

Zinc fortified group

EXPERIMENTAL

Daily consumption of zinc-fortified complementary food

Dietary Supplement: Zinc fortified foodOther: Placebo supplement

Non-fortified group

PLACEBO COMPARATOR

Daily consumption of non-fortified complementary food and placebo supplement.

Other: Placebo supplementDietary Supplement: Non-fortified food

Zinc supplement group

EXPERIMENTAL

Daily consumption of zinc supplement and non-fortified complementary food.

Dietary Supplement: Zinc supplementDietary Supplement: Non-fortified food

Interventions

Zinc fortified foodDIETARY_SUPPLEMENT

Daily consumption

Also known as: Provital, CoAID
Zinc fortified group
Zinc supplementDIETARY_SUPPLEMENT

Liquid supplement containing zinc sulfate

Also known as: Zinc sulfate and B vitamins, DSM
Zinc supplement group
Placebo supplementOTHER

Liquid placebo supplement

Also known as: B vitamins, DSM
Non-fortified groupZinc fortified group
Non-fortified foodDIETARY_SUPPLEMENT

Non-fortified complementary food.

Also known as: Provital, CoAID
Non-fortified groupZinc supplement group

Eligibility Criteria

Age12 Months - 17 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • apparently healthy

You may not qualify if:

  • severe malnutrition
  • severe anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen Keller International

Dakar, Senegal

Location

Related Publications (1)

  • Lo NB, Aaron GJ, Hess SY, Dossou NI, Guiro AT, Wade S, Brown KH. Plasma zinc concentration responds to short-term zinc supplementation, but not zinc fortification, in young children in Senegal1,2. Am J Clin Nutr. 2011 Jun;93(6):1348-55. doi: 10.3945/ajcn.111.012278. Epub 2011 Apr 13.

    PMID: 21490143DERIVED

MeSH Terms

Interventions

Zinc SulfateVitamin B Complex

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc CompoundsVitaminsMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Kenneth H Brown, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

February 19, 2010

Record last verified: 2010-02

Locations

SE(1)