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
Status | Recruiting |
Enrollment | 300 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 17 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Congo | Safe Motherhood Cohort | Idgwi Island | South Kivu |
Lead Sponsor | Collaborator |
---|---|
Salmon, Margaret, M.D. | Akeso Associates, Bill and Melinda Gates Foundation, Eastern Congo Initiative, HEAL Hospital, DRC |
Congo,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 months | No |
Secondary | 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. | 12 months | No |
Secondary | hemoglobin | Subjects hemoglobin will be measured at study start, at 6 months and at 12 months | 12 months | No |
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