Effectiveness of Oral Albendazole in the Treatment of Sev... | NCT01395381

Studies
Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

NCT01395381

Sponsor

Washington University School of Medicine

Status

Withdrawn

Last Update Posted

Jan 28, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Kwashiorkor
Marasmus

Interventions

Placebo
Albendazole

Countries

Malawi

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not funded

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Not provided

First Submitted Date

Jul 1, 2011

First Submission Date that Met QC Criteria

Jul 13, 2011

First Posted Date

Jul 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2014

Last Update Posted Date

Jan 28, 2014Estimated

Name	Class
Kamuzu University of Health Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Albendazole	Experimental		Drug: Albendazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	placebo given once	Placebo
Albendazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
nutritional recovery	Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema	12 weeks
mortality		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
malnutrition relapse	acute malnutrition, either moderate (WHZ < -2) or severe (WHZ < -3 and/or bipedal pitting edema)	6 months
height and weight gain		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

59 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Louis Nutrition Project		Blantyre			Malawi

Condition Browse Module

MeSH Terms

ID	Term
D007732	Kwashiorkor
D011502	Protein-Energy Malnutrition

Ancestor Terms

ID	Term
D000067011	Severe Acute Malnutrition
D044342	Malnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015766	Albendazole

Ancestor Terms

ID	Term
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided