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

Tracking Information

First Received Date ^ICMJE

January 22, 2008

Last Updated Date

February 4, 2008

Start Date ^ICMJE

June 2003

Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

nutritional status [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00607074 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

intestinal permeability [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh

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.

Detailed Description

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver)
Primary Purpose:  Treatment

Condition ^ICMJE

Giardiasis

Intervention ^ICMJE

Drug: 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)
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
Drug: Control group (placebo)
Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo

Study Arms / Comparison Groups

1: Experimental

Interventions:

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

Publications *

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. Epub 2008 Sep 11.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

410

Completion Date

December 2006

Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

infants living in the study area

Gender

Both

Ages

3 Months to 15 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Bangladesh

Administrative Information

NCT ID ^ICMJE

NCT00607074

Responsible Party

Dr Rie Goto, Department of Biological Anthropology, University of Cambridge

Study ID Numbers ^ICMJE

BMRC/ERC/2001-2004/2281, BMRC/ERC/2001-2004/2281

Study Sponsor ^ICMJE

University of Cambridge

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Nicholas C Mascie-Taylor, ScD

Department of Biological Anthropology, University of Cambridge

Information Provided By

University of Cambridge

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP