Directly Observed Iron Supplementation to Treat Anemia

NCT01129843 | Completed DMC

• 1 other identifier: No.SSD/WS/102/2008
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

anemia; iron deficiency; nutritional; iron supplementation; cluster randomized control trial

Outcome Measures

Primary Outcomes (1)

• Prevalence of anemia

  Compare the prevalence of anemia in two cluster randomized groups of villages

  1 year

Secondary Outcomes (1)

• Compliance with iron therapy

  1 year

Study Arms (2)

Directly observed home based daily iron therapy

EXPERIMENTAL

Village volunteers will provide directly observed home based daily iron supplementation( ferrous sulphate) to enrolled anemic women in the experimental arm

Drug: Directly observed home based daily iron therapy

Clinic driven unsupervised daily iron therapy

ACTIVE COMPARATOR

In the control group of villages, clinic driven unsupervised iron ( ferrous sulphate) supplementation will be offered on monthly basis to anemic women for 3 months

Drug: Directly observed home based daily iron therapy

Interventions

Directly observed home based daily iron therapy DRUG

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

Clinic driven unsupervised daily iron therapy; Directly observed home based daily iron therapy

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and adolescent girls aged 13 years and above who are diagnosed with anemia using WHO defined cut-offs for hemoglobin levels

You may not qualify if:

• Any active medical disease ( acute or chronic)other than anemia, any subject already on iron supplementation for \>4 weeks, any subject with significant mental impairment, recent history of Gastrointestinal bleed

Sponsors & Collaborators

• Build Healthy India Movement: lead
• Ministry of Science and Technology, India: collaborator

Study Sites (1)

Build Healthy India Movement

Sirmaur, Himachal Pradesh, India

Location

Related Publications (1)

• Bharti S. Feasibility of "directly observed home-based twice-daily iron therapy" (DOHBIT) for management of anemia in rural patients: a pilot study. Indian J Med Sci. 2004 Oct;58(10):431-8.

  PMID: 15523164 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dr Sahul Bharti, MD Pediatrics, PDCC, Dip Stats

  Build Healthy India Movement (BHIM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2010
• First Posted: May 25, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 1, 2011

Record last verified: 2011-05

Locations

IN (1)