Does Treating Hookworm Improve Productivity of Small Subsistence Farmers

NCT02102321 | Unknown

• 1 other identifier: HW0001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of hookworm infected groups with albendazole has been shown to result in an increase in hemoglobin levels and a related decrease in the prevalence of anemia. Increases in hemoglobin levels due to treatment have been associated with significant gains in adult labor productivity. In this study, the investigators hypothesize that regular treatment of women smallholder farmers in a high prevalence area with the anti-hookworm drug albendazole and iron supplementation will improve hookworm associated anemia. Further, regular treatment of albendazole and iron supplementation will improve their work capacity when compared to a control group

Conditions

Hookworm Stool Burden; Anemia; Exercise Tolerance

Keywords

hookworm; albendazole; iron supplementation; democratic republic of congo; subsistence farmers; randomized control trial; neglected tropical disease; helminths

Outcome Measures

Primary Outcomes (1)

• Exercise Tolerance Harvard STEP Test

  Subjects exercise tolerance will be measured as amount of time able to step on and off the Harvard Step and the heart rate as measured in beats per minute after a 5 minute step interval

  12 months

Secondary Outcomes (2)

• albendazole efficacy

  12 months

• hemoglobin

  12 months

Study Arms (2)

albendazole

EXPERIMENTAL

albendazole 400 mg

Drug: albendazole

placebo

ACTIVE COMPARATOR

placebo

Drug: placebo

Interventions

albendazole DRUG

albendazole

placebo DRUG

placebo

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All women of childbearing years (age 16 - 50)
• Identify as a small subsistence farmer
• No clinical evidence of acute malaria, who are with hookworm + stool, and are not pregnant.
• If women become pregnant during the period of study and tests + at the 6 or 12 month study visit then based on last menstrual period, we will wait until she has completed her first trimester to initiate the 6 or 12 month study visit based on protocol.

You may not qualify if:

• Women with acute symptoms of malaria
• st trimester pregnancy
• Hookworm - stool
• Declines study participation
• Age \<16 or \> 50
• Muscular or neurologic defect that preclude them from stepping on and off a stairs
• Cognitive impairment such that they cannot understand study purpose and consenting procedure

Sponsors & Collaborators

• Salmon, Margaret, M.D.: lead
• Akeso Associates: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Eastern Congo Initiative: collaborator
• HEAL Hospital, DRC: collaborator

Study Sites (1)

Safe Motherhood Cohort

Idgwi Island, South Kivu, Republic of the Congo

RECRUITING

MeSH Terms

Conditions

Anemia; Ancylostomiasis; Neglected Diseases

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Hookworm Infections; Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Margaret Salmon, MD MPH

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Christian Salmon, DrSc

  Western New England University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Salmon, MD MPH

CONTACT

647 704 5938; margiesalmon@gmail.com

Christian Salmon, DrSc

CONTACT

+1 202 251 9503; salmon@gwmail.gwu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2014
• First Posted: April 2, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 2, 2014

Record last verified: 2014-03

Locations

RE (1)