Back to resultsImpact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh
Primary Purpose
Giardiasis
Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)
Anti-Giardia treatment only (secnidazole or albendazole)
Control group (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Giardiasis
Eligibility Criteria
Inclusion Criteria:
- infants living in the study area
Sites / Locations
- National Institute of Preventive and Social Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
nutritional status
Secondary Outcome Measures
intestinal permeability
Full Information
NCT ID
NCT00607074
First Posted
January 22, 2008
Last Updated
February 4, 2008
Sponsor
University of Cambridge
1. Study Identification
Unique Protocol Identification Number
NCT00607074
Brief Title
Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh
Official Title
Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cambridge
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giardiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
410 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)
Intervention Description
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
Intervention Name(s)
Anti-Giardia treatment only (secnidazole or albendazole)
Intervention Description
Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) Every 12 weeks: placebo of Albendazole
Intervention Type
Drug
Intervention Name(s)
Control group (placebo)
Intervention Description
Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo
Primary Outcome Measure Information:
Title
nutritional status
Time Frame
9 months
Secondary Outcome Measure Information:
Title
intestinal permeability
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
infants living in the study area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas C Mascie-Taylor, ScD
Organizational Affiliation
Department of Biological Anthropology, University of Cambridge
Official's Role
Study Chair
Facility Information:
Facility Name
National Institute of Preventive and Social Medicine
City
Mohakhali
State/Province
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
12. IPD Sharing Statement
Citations:
PubMed Identifier
18789466
Citation
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.
Results Reference
derived
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Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh
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