Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh

NCT ID: NCT00607074

Last Updated: 2008-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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A randomised double-blind controlled intervention of 36 weeks duration was conducted in a rural community located 40kms north-west of Dhaka, the capital of Bangladesh. Infants aged between 3 and 11 months were randomly assigned to either receiving anti-Giardia and antihelmintic treatment, or anti-Giardia treatment only, or a control group receiving placebos. Weight and supine length were recorded every 4 weeks. Every 12 weeks intestinal permeability (L/M ratio), haemoglobin, plasma albumin, alpha-1-acid glycoprotein, immunoglobulin G and Giardia intestinalis specific IgM titre (GSIgM) and eggs of the three common geohelminths and Giardia intestinalis cysts were determined.

Conditions

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Giardiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

Group Type EXPERIMENTAL

Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)

Intervention Type 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)

Anti-Giardia treatment only (secnidazole or albendazole)

Intervention Type DRUG

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

Control group (placebo)

Intervention Type DRUG

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

Interventions

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Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)

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)

Intervention Type DRUG

Anti-Giardia treatment only (secnidazole or albendazole)

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

Intervention Type DRUG

Control group (placebo)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* infants living in the study area
Minimum Eligible Age

3 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cambridge

OTHER

Sponsor Role lead

Responsible Party

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Department of Biological Anthropology, University of Cambridge

Principal Investigators

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Nicholas C Mascie-Taylor, ScD

Role: STUDY_CHAIR

Department of Biological Anthropology, University of Cambridge

Locations

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National Institute of Preventive and Social Medicine

Mohakhali, Dhaka Division, Bangladesh

Site Status

Countries

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Bangladesh

References

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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.

Reference Type DERIVED
PMID: 18789466 (View on PubMed)

Other Identifiers

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BMRC/ERC/2001-2004/2281

Identifier Type: -

Identifier Source: secondary_id

BMRC/ERC/2001-2004/2281

Identifier Type: -

Identifier Source: org_study_id

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