Hookworm Stool BurdenNCT02102321
Does Treating Hookworm Improve Productivity of Small Subsistence Farmers
A study testing albendazole in people with Hookworm Stool Burden and Anemia, run by Salmon, Margaret, M.D. at 1 site in Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 50 years, women only
- Conditions the study is for
- Hookworm Stool Burden, Anemia, Exercise Tolerance
- What is being tested?
- albendazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- Mar 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Republic of the Congo1 site, 1 recruiting
- Recruiting
Safe Motherhood Cohort
Idgwi Island, South Kivu
Maurice Masoda, MD, mauricemas@yahoo.fr
Maurice Masoda, MD
About this study
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
Read the detailed description
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
- To determine prevalence of hookworm infection in the Safe Motherhood cohort
- To determine the prevalence of anemia in the Safe Motherhood cohort
- 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.
- 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
- Conditions
- Hookworm Stool Burden, Anemia, Exercise Tolerance
- Being tested
- albendazole, placebo
- Keywords
- hookworm, albendazole, iron supplementation, democratic republic of congo, subsistence farmers, randomized control trial, neglected tropical disease, helminths
- Medical subject headings
- Anemia, Ancylostomiasis, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albendazoleDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| albendazole | Experimental | albendazole 400 mg Receives: Drug: albendazole |
| placebo | Active comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
albendazole efficacy
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.
Measured: 12 months
hemoglobin
Subjects hemoglobin will be measured at study start, at 6 months and at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hookworm Stool BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salmon, Margaret, M.D.
- Collaborators
- Akeso Associates, Bill and Melinda Gates Foundation, Eastern Congo Initiative, HEAL Hospital, DRC
- Responsible party
- Sponsor
- Investigators
- Margaret Salmon, MD MPH, Principal investigator, University Health Network, TorontoChristian Salmon, DrSc, Principal investigator, Western New England University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102321
- Sponsor's protocol ID
- HW0001
- Status last verified
- Mar 2014
- First submitted
- 29 Mar 2014
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Effectiveness Trial of Hookworm Treatment of Women Smallholder Farmers to Evaluate Improved Productivity of Their Farming and/or Household Labor
- ClinicalTrials.gov ID
- NCT02102321
- Acronym / sponsor ID
- HW0001
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Salmon, Margaret, M.D.
- Collaborators
- Akeso Associates, Bill and Melinda Gates Foundation, Eastern Congo Initiative, HEAL Hospital, DRC
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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
- To determine prevalence of hookworm infection in the Safe Motherhood cohort
- To determine the prevalence of anemia in the Safe Motherhood cohort
- 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| albendazole | Experimental | Drug: albendazolealbendazole 400 mg |
| placebo | Active comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Women with acute symptoms of malaria
- 1st trimester pregnancy
- Hookworm - stool
- Declines study participation
- Age <16 or > 50
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albendazole | Drug | albendazole |
| placebo | Drug | placebo |
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
2 secondary outcomes
albendazole efficacy
Time frame: 12 months
hemoglobin
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Salmon, MD MPH principal investigator
University Health Network, Toronto
Christian Salmon, DrSc principal investigator
Western New England University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing albendazole in people with Hookworm Stool Burden and Anemia, run by Salmon, Margaret, M.D. at 1 site in Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margaret Salmon, MD MPH (647 704 5938, margiesalmon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Tolerance Harvard STEP Test (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.