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Does Treating Hookworm Improve Productivity of Small Subsistence Farmers

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ClinicalTrials.gov Identifier: NCT02102321
Recruitment Status : Unknown
Verified March 2014 by Salmon, Margaret, M.D..
Recruitment status was:  Recruiting
First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Collaborators:
Akeso Associates
Bill and Melinda Gates Foundation
Eastern Congo Initiative
HEAL Hospital, DRC
Information provided by (Responsible Party):
Salmon, Margaret, M.D.

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


Condition or disease Intervention/treatment Phase
Hookworm Stool Burden Anemia Exercise Tolerance Drug: albendazole Drug: placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Effectiveness Trial of Hookworm Treatment of Women Smallholder Farmers to Evaluate Improved Productivity of Their Farming and/or Household Labor
Study Start Date : March 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

Arm Intervention/treatment
Experimental: albendazole
albendazole 400 mg
Drug: albendazole
Active Comparator: placebo
placebo
Drug: placebo



Primary Outcome Measures :
  1. Exercise Tolerance Harvard STEP Test [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. albendazole efficacy [ Time Frame: 12 months ]
    subjects stool will be retested for hookworm burden at 14 days and 3 months after treatment with albendazole to determine the percentage treatment failure rate.

  2. hemoglobin [ Time Frame: 12 months ]
    Subjects hemoglobin will be measured at study start, at 6 months and at 12 months



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Ages Eligible for Study:   17 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Women with acute symptoms of malaria
  • 1st 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102321


Contacts
Contact: Margaret Salmon, MD MPH 647 704 5938 margiesalmon@gmail.com
Contact: Christian Salmon, DrSc +1 202 251 9503 salmon@gwmail.gwu.edu

Locations
Congo
Safe Motherhood Cohort Recruiting
Idgwi Island, South Kivu, Congo
Contact: Maurice Masoda, MD       mauricemas@yahoo.fr   
Principal Investigator: Maurice Masoda, MD         
Sponsors and Collaborators
Salmon, Margaret, M.D.
Akeso Associates
Bill and Melinda Gates Foundation
Eastern Congo Initiative
HEAL Hospital, DRC
Investigators
Principal Investigator: Margaret Salmon, MD MPH University Health Network, Toronto
Principal Investigator: Christian Salmon, DrSc Western New England University

Responsible Party: Salmon, Margaret, M.D.
ClinicalTrials.gov Identifier: NCT02102321     History of Changes
Other Study ID Numbers: HW0001
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: March 2014

Keywords provided by Salmon, Margaret, M.D.:
hookworm
albendazole
iron supplementation
democratic republic of congo
subsistence farmers
randomized control trial
neglected tropical disease
helminths

Additional relevant MeSH terms:
Hookworm Infections
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents