Does Treating Hookworm Improve Productivity of Small Subsistence Farmers

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02102321
• Date of registration: 29/03/2014
• Prospective Registration: No
• Primary sponsor: Salmon, Margaret, M.D.
• Public title: Does Treating Hookworm Improve Productivity of Small Subsistence Farmers
• Scientific title: A Randomized Effectiveness Trial of Hookworm Treatment of Women Smallholder Farmers to Evaluate Improved Productivity of Their Farming and/or Household Labor
• Date of first enrolment: March 2014
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02102321
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Congo

Contacts

• Name: Maurice Masoda, MD

• Name: Margaret Salmon, MD MPH
• Affiliation: University Health Network, Toronto

• Name: Margaret Salmon, MD MPH

• Name: Christian Salmon, DrSc
• Affiliation: Western New England University

Key inclusion & exclusion 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



Age minimum: 17 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Exercise Tolerance

Anemia

Hookworm Stool Burden

Intervention(s)

Drug: placebo

Drug: albendazole

Primary Outcome(s)

Exercise Tolerance Harvard STEP Test [Time Frame: 12 months]

Secondary Outcome(s)

albendazole efficacy [Time Frame: 12 months]

hemoglobin [Time Frame: 12 months]

Secondary ID(s)

HW0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bill and Melinda Gates Foundation

HEAL Hospital, DRC

Akeso Associates

Eastern Congo Initiative