Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

Kwashiorkor Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Benefit of Antihelminthic Therapy in the Community-Based Treatment of Severe Acute Malnutrition in Malawian Children

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01395381
• Other study ID #: MJM-albendazole
• Status: Withdrawn
• Phase: N/A
• First received: July 1, 2011
• Last updated: January 24, 2014
• Start date: January 2013

Study information

• Verified date: January 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The benefit of anti-worm therapy as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not previously been studied. This study will compare recovery rates of children with SAM treated in the community with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of their case management.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• 12-59 months old

• Kwashiorkor and/or Marasmus

• Qualified for home-based therapeutic feeding with RUTF

Exclusion Criteria:

• Obvious congenital or other malformation that makes child a poor candidate for feeding with RUTF

• Unable to consume test-dose of RUTF in clinic

• Parent refusal to participate and return for follow-up

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kwashiorkor
• Malnutrition
• Marasmus

Intervention

Drug:
• Placebo
placebo given once
• Albendazole
single dose albendazole given at the time of enrollment

Locations

Country	Name	City	State
Malawi	St. Louis Nutrition Project	Blantyre

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nutritional recovery	Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema	12 weeks	No
Primary	mortality		12 weeks	No
Secondary	malnutrition relapse	acute malnutrition, either moderate (WHZ < -2) or severe (WHZ < -3 and/or bipedal pitting edema)	6 months	No
Secondary	height and weight gain		6 months	No