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

Giardiasis Clinical Trial

Official title:

Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607074
• Other study ID #: BMRC/ERC/2001-2004/2281
• Secondary ID: BMRC/ERC/2001-20
• Status: Completed
• Phase: N/A
• First received: January 22, 2008
• Last updated: February 4, 2008
• Start date: June 2003
• Est. completion date: December 2006

Study information

• Verified date: January 2008
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: December 2006
• Est. primary completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 15 Months

Eligibility

Inclusion Criteria:

• infants living in the study area

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Giardiasis

Intervention

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)
• 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
• Control group (placebo)
Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo

Locations

Country	Name	City	State
Bangladesh	National Institute of Preventive and Social Medicine	Mohakhali	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
University of Cambridge

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nutritional status		9 months	No
Secondary	intestinal permeability		9 months	No