Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh
This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants...
Brief Summary
Official Title: “Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh”
This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
- Study Primary Completion Date: April 2004
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
Outcome Measures for this Clinical Trial
Primary Measures
- nutritional status
- Time Frame: 9 months
Safety Issue?: No
- Time Frame: 9 months
Secondary Measures
- intestinal permeability
- Time Frame: 9 months
Safety Issue?: No
- Time Frame: 9 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- infants living in the study area
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 3 Months
Maximum Age for this Clinical Trial: 15 Months
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: University of Cambridge Other
Overall Clinical Trial Officials and Contacts
Nicholas C Mascie-Taylor, ScD Study Chair Department of Biological Anthropology, University of Cambridge
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00607074
Study ID Number: BMRC/ERC/2001-2004/2281
ClinicalTrials.gov Identifier: NCT00607074
Health Authority: Bangladesh: Ethical Review Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00607074
