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

This study has been completed.
Sponsor:
Information provided by:
University of Cambridge
ClinicalTrials.gov Identifier:
NCT00607074
First received: January 22, 2008
Last updated: February 4, 2008
Last verified: January 2008
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • nutritional status [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intestinal permeability [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: June 2003
Study Completion Date: December 2006
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

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.

  Eligibility

Ages Eligible for Study:   3 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • infants living in the study area
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607074

Locations
Bangladesh
National Institute of Preventive and Social Medicine
Mohakhali, Dhaka, Bangladesh, 1212
Sponsors and Collaborators
University of Cambridge
Investigators
Study Chair: Nicholas C Mascie-Taylor, ScD Department of Biological Anthropology, University of Cambridge
  More Information

No publications provided by University of Cambridge

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Rie Goto, Department of Biological Anthropology, University of Cambridge
ClinicalTrials.gov Identifier: NCT00607074     History of Changes
Other Study ID Numbers: BMRC/ERC/2001-2004/2281, BMRC/ERC/2001-2004/2281
Study First Received: January 22, 2008
Last Updated: February 4, 2008
Health Authority: Bangladesh: Ethical Review Committee

Additional relevant MeSH terms:
Giardiasis
Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Albendazole
Anthelmintics
Secnidazole
Metronidazole
Anticestodal Agents
Antiplatyhelmintic Agents
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013