NCT00607074

Brief Summary

This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 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

Study Start

First participant enrolled

June 1, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
Last Updated

February 5, 2008

Status Verified

January 1, 2008

Enrollment Period

10 months

First QC Date

January 22, 2008

Last Update Submit

February 4, 2008

Conditions

Giardiasis

Outcome Measures

Primary Outcomes (1)

  • nutritional status

    9 months

Secondary Outcomes (1)

  • intestinal permeability

    9 months

Study Arms (1)

1

EXPERIMENTAL
Drug: Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)Drug: Anti-Giardia treatment only (secnidazole or albendazole)Drug: Control group (placebo)

Interventions

Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)DRUG

Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) or a placebo was administered Every 12 weeks: Albendazole (syrup, 200mg)

1
Anti-Giardia treatment only (secnidazole or albendazole)DRUG

Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) Every 12 weeks: placebo of Albendazole

1
Control group (placebo)DRUG

Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo

1

Eligibility Criteria

Age3 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • infants living in the study area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Preventive and Social Medicine

Mohakhali, Dhaka Division, 1212, Bangladesh

Location

Related Publications (1)

  • Goto R, Mascie-Taylor CG, Lunn PG. Impact of anti-Giardia and anthelminthic treatment on infant growth and intestinal permeability in rural Bangladesh: a randomised double-blind controlled study. Trans R Soc Trop Med Hyg. 2009 May;103(5):520-9. doi: 10.1016/j.trstmh.2008.07.020. Epub 2008 Sep 11.

    PMID: 18789466DERIVED

MeSH Terms

Conditions

Giardiasis

Interventions

secnidazoleAlbendazoleControl Groups

Condition Hierarchy (Ancestors)

Intestinal Diseases, ParasiticParasitic DiseasesInfectionsProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Nicholas C Mascie-Taylor, ScD

    Department of Biological Anthropology, University of Cambridge

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

June 1, 2003

Primary Completion

April 1, 2004

Study Completion

December 1, 2006

Last Updated

February 5, 2008

Record last verified: 2008-01

Locations

BA(1)