NCT00325247

Brief Summary

Diarrhoea continues to be a major cause of mortality and morbidity in young children especially in many developing countries. Although the mortality burden of diarrhoea has substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized controlled supplementation trials in developing countries have consistently shown that zinc has the potential to reduce the duration of diarrhoea as well as has preventive effect on childhood diarhroea in subsequent months. Currently, international health agencies recommend zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc deficiency is highly prevalent and diet is poor in zinc. The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode of diarrhoea. This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs 10 days) during acute diarrhoea in a rural community in a community-based individually randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven villages in the ICDDR,B Matlab study area. The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days). Children who will be allocated to the shorter duration therapy will receive placebo for the remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using appropriate statistical procedure. Findings of this study will be immensely valuable for deciding recommendation for the duration of zinc therapy in the management of acute diarrhoea in young children and will have profound programmatic and policy implications for scaling up zinc intervention in the community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,050

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3

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

February 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
Last Updated

July 12, 2011

Status Verified

May 1, 2006

Enrollment Period

1.2 years

First QC Date

May 11, 2006

Last Update Submit

July 11, 2011

Conditions

Acute Watery Diarrhoea

Keywords

ZINC SUPPLEMENTATIONACUTE DIARRHOEAUNDER FIVE CHILDRENRURAL BANGLADESH

Outcome Measures

Primary Outcomes (2)

  • Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment

  • Assess the acceptability of zinc therapy during diarrhoea in young children.

Secondary Outcomes (2)

  • Compare the duration of current episode in two groups receiving 5 d vs 10 d zinc.

  • Compare the proportion of children developing prolonged (>10 d) or persistent diarrheoa (>14 d).

Interventions

ZINCDRUG

Eligibility Criteria

Age1 Month - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children less than 5 years with acute watery diarrhoea less than 48 h of duration
  • No medication received other than ORS or home solution
  • Absence of complication or co-morbidities.
  • Absence of severe dehydration

You may not qualify if:

  • Age greater than 5 years
  • Diarrhoea more than 48 h duration
  • Unable to eat or drink
  • Already received multiple treatment including zinc
  • Presence of co-morbidities
  • Severe dehydration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICDDR,B

Dhaka, 1000, Bangladesh

Location

Related Publications (1)

  • Alam DS, Yunus M, El Arifeen S, Chowdury HR, Larson CP, Sack DA, Baqui AH, Black RE. Zinc treatment for 5 or 10 days is equally efficacious in preventing diarrhea in the subsequent 3 months among Bangladeshi children. J Nutr. 2011 Feb;141(2):312-5. doi: 10.3945/jn.110.120857. Epub 2010 Dec 8.

    PMID: 21147907DERIVED

MeSH Terms

Interventions

Zinc

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Dewan S Alam, PhD

    ICDDR,B: Centre for Health and Population Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 12, 2006

Study Start

February 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

July 12, 2011

Record last verified: 2006-05

Locations

BA(1)