Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01395381
• Collaborator: University of Malawi College of Medicine (Other)
• Enrollment: 0
• Location: 1
• Arms: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kwashiorkor; Marasmus	Drug: Placebo; Drug: Albendazole	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2013
• Anticipated Primary Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo; placebo given once
Experimental: Albendazole	Drug: Albendazole; single dose albendazole given at the time of enrollment

Outcome Measures

Primary Outcome Measures

1. nutritional recovery [12 weeks]

   Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema

2. mortality [12 weeks]

Secondary Outcome Measures

1. malnutrition relapse [6 months]

   acute malnutrition, either moderate (WHZ < -2) or severe (WHZ < -3 and/or bipedal pitting edema)

2. height and weight gain [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 59 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Louis Nutrition Project	Blantyre		Malawi

Sponsors and Collaborators

• Washington University School of Medicine
• University of Malawi College of Medicine

Investigators

• Principal Investigator: Mark J Manary, MD, University of Malawi
• Principal Investigator: Kenneth Maleta, MBBS PhD, University of Malawi
• Study Director: Indi Trehan, MD MPH DTM&H, University of Malawi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01395381
• Other Study ID Numbers: MJM-albendazole
• First Posted: Jul 15, 2011
• Last Update Posted: Jan 28, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Malnutrition; Severe Acute Malnutrition; Kwashiorkor; Protein-Energy Malnutrition; Albendazole

Study Results

No Results Posted as of Jan 28, 2014