Anemia Clinical Trial
Official title:
A Randomized Effectiveness Trial of Hookworm Treatment of Women Smallholder Farmers to Evaluate Improved Productivity of Their Farming and/or Household Labor
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
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 high burden in Africa (25%), an
area which can least afford it. The median annual economic loss due to IDA has been
estimated at 4% of gross domestic product in 10 different developing countries.
Albendazole and Mebendazole are anti-helminthic drugs that that can cure or reduce the
severity (as measured by stool egg counts) of many hookworm infections. The major
programmatic use of these drugs is in programs of school-based mass drug administration
(MDA) as recommended treatment strategies have traditionally prioritized school-aged
children. Large amounts of these drugs are now being provided without charge by their
manufacturers, Merck and Johnson & Johnson respectively, and distributed through W.H.O. and
ministries of health to support current goals of control of pediatric hookworm and other STH
infections.
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 also been associated with significant gains in
adult labor productivity as measured in Kenyan road construction workers (16) and in
Bangladeshi women plantation tea pickers. However, the cure or amelioration of hookworm
infection caused by these drugs is not permanent; re-infection can occur within weeks or
months in heavily exposed people. Few studies have measured work productivity beyond 2-3
months and minimal information is available for longer term treatment.
This study is in response to the Bill and Melinda Gates Foundation Grand Challenges
Explorations RFP targeted specifically at "Labor Saving Strategies and Innovations for Women
Smallholder Farmers." As hookworm in endemic areas is thought to be one of the primary
causes of IDA and IDA is known to decrease work productivity, then subsistence farmers will
ideally report improved productivity if hookworm is treated. Although the benefits of this
proposed intervention are not directly targeted at that specific goal, i.e., are not
intended to reduce the amount of necessary labor, the benefits of this intervention could
lead indirectly to the same result(s) through an increase of women's ability to accomplish a
fixed amount of work.
The Democratic Republic of Congo is thought to be an appropriate location as it has one of
the world's highest burdens of NTD disease with an estimated 31 million hookworm cases,
second only to Nigeria for disease prevalence in Africa. The population is also particularly
vulnerable as moderate to heavy hookworm infections has been associated with lower
hemoglobin levels (in both children and adults) and thus with a greater risk of iron
deficiency and anemia. DRC has also been identified by USAID as a country in need of urgent
NTD disease surveillance and control activities. Information from this study will ideally
extend understanding of this disease process and provide information regarding inclusion of
anthelmintic treatment in maternal and other public health packages.
Study Purpose The purpose of this study is to determine whether regular treatment of women
smallholder farmers with the anti-hookworm drug Albendazole over a one-year period would
have an impact on their work capacity and possible productivity as small farmers. The
intention is to identify and enroll in an intervention study a group of women smallholder
farmers who are not pregnant in their first trimester of pregnancy, are not acutely ill with
malaria, and living in areas with poor sanitation and with endemic hookworm. Many of these
women would presumably be iron deficient, at least in part due to the blood loss associated
with hookworm infection.
Study Aims
1. To determine prevalence of hookworm infection in the Safe Motherhood cohort
2. To determine the prevalence of anemia in the Safe Motherhood cohort
3. To determine the change in Hemoglobin of female subsistence small farmers who have been
treated with Albendazole and daily iron supplementation at 6 and 12 months.
4. To determine the change in work tolerance as measured by the STEP test when female
subsistence small farmers have been given Albenzazole and iron supplementation at 6 and
12 months
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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