NCT00944723

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 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

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
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 19, 2010

Status Verified

February 1, 2010

Enrollment Period

5 months

First QC Date

July 21, 2009

Last Update Submit

February 18, 2010

Conditions

Zinc Deficiency

Keywords

zinc fortificationzinc supplementationplasma zinc concentration

Outcome Measures

Primary Outcomes (1)

  • Plasma zinc concentration

    1 month

Study Arms (4)

Zinc-fortified bread (10 mg zinc/d)

EXPERIMENTAL

Daily consumption of zinc fortified bread for 1 month

Dietary Supplement: Zinc-fortified breadDietary Supplement: Placebo supplement

Zinc fortified bread (20 mg zinc/d)

EXPERIMENTAL

Daily consumption of zinc fortified bread for 1 month.

Dietary Supplement: Zinc-fortified breadDietary Supplement: Placebo supplement

Zinc supplemented group

EXPERIMENTAL

Daily consumption of non-fortified bread and daily intake of zinc supplement (10 mg zinc/d)

Dietary Supplement: Zinc supplementDietary Supplement: Non-fortified bread

Non-fortified group

PLACEBO COMPARATOR

Daily consumption of non-fortified bread and a placebo supplement for 1 month.

Dietary Supplement: Non-fortified breadDietary Supplement: Placebo supplement

Interventions

Zinc-fortified breadDIETARY_SUPPLEMENT

Bread made with zinc-fortified wheat flour

Also known as: Les Grands Moulins de Dakar
Zinc fortified bread (20 mg zinc/d)Zinc-fortified bread (10 mg zinc/d)
Zinc supplementDIETARY_SUPPLEMENT

Liquid supplement with zinc

Also known as: Zinc sulfate and B vitamins, DSM
Zinc supplemented group
Non-fortified breadDIETARY_SUPPLEMENT

Daily consumption of non-fortified bread

Also known as: Les Grands Moulins de Dakar
Non-fortified groupZinc supplemented group
Placebo supplementDIETARY_SUPPLEMENT

Daily intake of placebo supplement

Also known as: B-vitamins, DSM
Non-fortified groupZinc fortified bread (20 mg zinc/d)Zinc-fortified bread (10 mg zinc/d)

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • apparently healthy males

You may not qualify if:

  • Hemoglobin \<80 g/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen Keller International

Dakar, Senegal

Location

Related Publications (1)

  • Aaron GJ, Ba Lo N, Hess SY, Guiro AT, Wade S, Brown KH. Plasma zinc concentration increases within 2 weeks in healthy Senegalese men given liquid supplemental zinc, but not zinc-fortified wheat bread. J Nutr. 2011 Jul;141(7):1369-74. doi: 10.3945/jn.110.136952. Epub 2011 May 11.

    PMID: 21562238DERIVED

MeSH Terms

Interventions

Zinc SulfateVitamin B ComplexFolic Acid

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc CompoundsVitaminsMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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

August 1, 2009

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

February 19, 2010

Record last verified: 2010-02

Locations

SE(1)