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| Sponsor: | University of Cambridge |
|---|---|
| Information provided by: | University of Cambridge |
| ClinicalTrials.gov Identifier: | NCT00607074 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh |
| 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 |
|---|---|
| 1: Experimental |
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
|
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 |
Inclusion Criteria:
Contacts and Locations| Bangladesh, Dhaka | |
| National Institute of Preventive and Social Medicine | |
| Mohakhali, Dhaka, Bangladesh, 1212 | |
| Study Chair: | Nicholas C Mascie-Taylor, ScD | Department of Biological Anthropology, University of Cambridge |
More Information
| Responsible Party: | Department of Biological Anthropology, University of Cambridge ( Dr Rie Goto ) |
| Study ID Numbers: | BMRC/ERC/2001-2004/2281, BMRC/ERC/2001-2004/2281 |
| Study First Received: | January 22, 2008 |
| Last Updated: | February 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00607074 History of Changes |
| Health Authority: | Bangladesh: Ethical Review Committee |
|
Anti-Infective Agents Protozoan Infections Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiplatyhelmintic Agents Gastrointestinal Diseases Mitosis Modulators Mastigophora Infections Anthelmintics Antimitotic Agents Giardiasis |
Intestinal Diseases Pharmacologic Actions Anticestodal Agents Albendazole Antiparasitic Agents Digestive System Diseases Therapeutic Uses Secnidazole Tubulin Modulators Parasitic Diseases Sarcomastigophora Infections Intestinal Diseases, Parasitic |
