NCT01306097

Brief Summary

Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

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
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
Last Updated

March 1, 2011

Status Verified

January 1, 2009

Enrollment Period

1 year

First QC Date

February 28, 2011

Last Update Submit

February 28, 2011

Conditions

Diarrhea

Keywords

Zinc SupplementDiarrheaSever Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Diarrhea

    Incidence, Duration and frequency

    1 years

Secondary Outcomes (1)

  • Admission for diarrhea

    1 year

Study Arms (1)

Zinc sulfate

EXPERIMENTAL

daily zinc supplementation for 3 months. (10mg daily for under 1 years old children and 20mg daily for above 1 years old children)

Drug: Zinc Supplement

Interventions

Zinc SupplementDRUG

10mg daily for under 1 years old children and 20mg daily for above 1 years old children

Also known as: Zinc sulfate, Oral Zinc
Zinc sulfate

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All 6 to 36 months old children without diarrhea at the time of study and without disease such as celiac
  • Inflammatory bowl disease and hypersensitivity to milk

You may not qualify if:

  • Diarrhea at the time of the study and background disease such as celiac, IBD or hypersensitivity to milk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hormozgan University of medical sciences

Bandar Abbas, Hormozgan, 79145-3388, Iran

Location

Related Publications (1)

  • Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.

    PMID: 36994923DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

Zinc SulfateZinc

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc CompoundsMetals, HeavyElementsTransition ElementsMetals

Study Officials

  • Marzie Barchinejad

    Hormozgan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 1, 2011

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

May 1, 2010

Last Updated

March 1, 2011

Record last verified: 2009-01

Locations

IR(1)