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Directly Observed Iron Supplementation to Treat Anemia

NCT01129843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2011-06-01

No results posted yet for this study

Summary

India continues to be one of the countries with very high prevalence of anemia. In fact, National Family Health Survey-3 (NFHS-3,2005-06) revealed increasing prevalence of anemia in women and children, since NFHS-2 in 1998-99. In the backdrop of this alarming trend, the aim of this trial is to assess the effectiveness of a community based anemia management intervention ( curative and holistic) delivered to rural anemia women and girls(aged 13 years and above)in remote hilly villages (unit of randomization) in terms of change in anemia prevalence (unit of analysis) after 3 months of iron supplementation. This trial with a therapeutic component of "Directly Observed Home Based daily Iron Therapy (DOHBIT)" by local village volunteers is conceived as a whole community approach to improve the hemoglobin status of affected patients in remote villages.

Conditions

  • Iron Deficiency Anemia (IDA)

Interventions

DRUG

Directly observed home based daily iron therapy

Directly Observed Home based Daily Iron( ferrous sulphate) therapy (DOHBIT) will be provided to the anemic women by the local village volunteers. Dose of elemental iron therapy will be 100 mg once daily for mild to moderate anemia and twice daily for severe anemia for a cumulative duration of 90 days

Sponsors & Collaborators

  • Ministry of Science and Technology, India

    collaborator OTHER_GOV

  • Build Healthy India Movement

    lead OTHER

Principal Investigators

  • Dr Sahul Bharti, MD Pediatrics, PDCC, Dip Stats · Build Healthy India Movement (BHIM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-01-31
Completion
2011-05-31

Countries

  • India

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129843 on ClinicalTrials.gov