Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh
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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 |
- nutritional status [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- infants living in the study area
Contacts and Locations| Bangladesh | |
| 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
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