Clinical Trial: Does Treating Hookworm Improve Productivity of Small Subsistence Farmers

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Effectiveness Trial of Hookworm Treatment of Women Smallholder Farmers to Evaluate Improved Productivity of Their Farming and/or Household Labor

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


Detailed Summary:

DRC has one of the world's highest prevalences (frequencies) of Soil Transmitted Helminths (STH), a group of intestinal parasites that include Ascaris, Trichuris and hookworm, each of which can have significant impacts on the health and nutritional status of children.(1)(2)(3) In addition, hookworm, because of prevalence increases noted during adulthood in many countries and because of its relationship to significant intestinal blood loss, can also have a significant impact on the health and nutritional status of adults.

Hookworm spreads easily in places without adequate control of feces; hookworm eggs are excreted in feces of infected people, transition to larvae, and usually enter the body through the skin on the bottom of the feet of other people who are not wearing footwear.

Much of hookworm's health impact is mediated through intestinal blood loss as hookworms attach to the human intestinal wall and digest the hemoglobin in human red blood cells. That blood loss leads to - or exacerbates - iron deficiency and eventually to iron deficiency anemia (IDA). Because of menstrual blood losses, the large iron demands of pregnancy, and the often low iron content of their diets, many women of childbearing age are at risk of iron deficiency even without hookworm exposure. Any blood loss associated with hookworm infection would exacerbate a pre-existing iron deficiency.

Iron deficiency with or without anemia has also been associated in several studies with lower aerobic work capacity. IDA can effect an individual's ability to perform economic generating tasks (work output) threaten one's livelihood and possibly food security. The World Health Organization (WHO) estimates an annual loss of 19.7 million disability-adjusted life years (1.3% of the global total) is due to IDA with hig
Sponsor: Salmon, Margaret, M.D.

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Salmon, Margaret, M.D.

Dates:
Date Received: March 29, 2014
Date Started: March 2014
Date Completion: August 2015
Last Updated: April 1, 2014
Last Verified: March 2014