Directly Observed Iron Supplementation to Treat Anemia (DOHBIT)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Technology, India
Information provided by:
Build Healthy India Movement
ClinicalTrials.gov Identifier:
NCT01129843
First received: May 22, 2010
Last updated: May 28, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Iron Deficiency Anemia (IDA)
Drug: Directly observed home based daily iron therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Cluster Randomized Trial for Lowering Prevalence of Anemia in Rural Hilly Villages With Directly Observed Home Based Daily Iron Therapy(DOHBIT)

Resource links provided by NLM:


Further study details as provided by Build Healthy India Movement:

Primary Outcome Measures:
  • Prevalence of anemia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare the prevalence of anemia in two cluster randomized groups of villages


Secondary Outcome Measures:
  • Compliance with iron therapy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To compare the degree of compliance with iron therapy by anemic women between two cluster randomized groups of villages


Estimated Enrollment: 1000
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Directly observed home based daily iron therapy
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
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
Active Comparator: Clinic driven unsupervised daily iron therapy
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
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

Detailed Description:

To combat iron deficiency anemia, the challenge is not so much knowing "what" to do, but to understand "how" to implement effective and sustainable interventions. In this perspective, the aim of this trial is to assess the effectiveness of a community based anemia management therapeutic intervention delivered to rural anemic women (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.

The intervention programme "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. A cluster-randomized trial will be thus the design of choice from the outset. For intervention arm of trial, each anemic patient will receive DOHBIT (Directly Observed Home Based daily Iron Therapy) by local village volunteer for a total of 90 days whereas in the control arm of trial each patient will receive usual standard iron therapy without daily supervision for the same duration. Information, educational and counseling strategies will be similar for the two groups.

Primary outcome will be the anemia prevalence (difference of proportions) in intervention vs. control groups after trial intervention. Secondary outcomes in two groups include mean hemoglobin levels, compliance and side effects of iron therapy, body mass index and quality of life scores.

Sample size estimates, adjusted for cluster randomization (assuming Intracluster Correlation Coefficient of 0.05 and mean cluster size of 30 patients/village based on our pilot study), show that with 10 villages, each for intervention and control groups, an average 300 anemic patients per treatment arm would need to be treated to provide sufficient power to determine a 20% difference in anemia prevalence in two groups- a reduction deemed to a worthwhile impact of the intervention to be reliably detected at 80% power.

Then a statistically valid approach to the analysis of primary outcome variable will be to calculate a single outcome measure for each randomized unit and apply standard parametric method (chi-square) to the set of summary measures, keeping in mind that any conclusion will be strictly applicable only at the cluster level. Since, covariate adjustment will be required on an individual level for various secondary outcomes, thus a different approach based on the individual, as unit of analysis, adjusting for clustering will be more appropriate in analyzing various secondary outcome measures.

Overall, DOHBIT is one of the strategies to increase the capacity of individuals and communities to define, analyze and act to address their own health needs. Moreover, in the supply-demand continuum, DOHBIT by utilizing facilitators and motivators at the local level will optimize demand as well as supply of iron supplementation programme in the community.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129843

Locations
India
Build Healthy India Movement
Sirmaur, Himachal Pradesh, India
Sponsors and Collaborators
Build Healthy India Movement
Ministry of Science and Technology, India
Investigators
Principal Investigator: Dr Sahul Bharti, MD Pediatrics, PDCC, Dip Stats Build Healthy India Movement (BHIM)
  More Information

Publications:
Responsible Party: Dr Sahul Bharti, Build Healthy India Movement
ClinicalTrials.gov Identifier: NCT01129843     History of Changes
Other Study ID Numbers: No.SSD/WS/102/2008
Study First Received: May 22, 2010
Last Updated: May 28, 2011
Health Authority: India: Ministry of Science and Technology

Keywords provided by Build Healthy India Movement:
anemia
iron deficiency
nutritional
iron supplementation
cluster randomized control trial

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Anemia, Hypochromic
Deficiency Diseases
Hematologic Diseases
Malnutrition
Nutrition Disorders
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014