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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607074
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : February 5, 2008
Sponsor:
Information provided by:
University of Cambridge

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.

Condition or disease Intervention/treatment Phase
Giardiasis Drug: Anti-Giardia and antihelmintic treatment (secnidazole or albendazole) Drug: Anti-Giardia treatment only (secnidazole or albendazole) Drug: Control group (placebo) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh
Study Start Date : June 2003
Actual Primary Completion Date : April 2004
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. nutritional status [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. intestinal permeability [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • infants living in the study area

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607074


Locations
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Bangladesh
National Institute of Preventive and Social Medicine
Mohakhali, Dhaka, Bangladesh, 1212
Sponsors and Collaborators
University of Cambridge
Investigators
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Study Chair: Nicholas C Mascie-Taylor, ScD Department of Biological Anthropology, University of Cambridge
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Rie Goto, Department of Biological Anthropology, University of Cambridge
ClinicalTrials.gov Identifier: NCT00607074    
Other Study ID Numbers: BMRC/ERC/2001-2004/2281
BMRC/ERC/2001-2004/2281
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: February 5, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
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Giardiasis
Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Albendazole
Anthelmintics
Secnidazole
Metronidazole
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Bacterial Agents