Iron Deficiency Anemia (IDA)DOHBITNCT01129843
Directly Observed Iron Supplementation to Treat Anemia
A study testing Directly observed home based daily iron therapy in people with Iron Deficiency Anemia (IDA), run by Build Healthy India Movement at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- Iron Deficiency Anemia (IDA)
- What is being tested?
- Directly observed home based daily iron therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteIndia
- Study dates
- May 2010to May 2011
- 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 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women and adolescent girls aged 13 years and above who are diagnosed with anemia using WHO defined cut-offs for hemoglobin levels
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Trial for Lowering Prevalence of Anemia in Rural Hilly Villages With Directly Observed Home Based Daily Iron Therapy(DOHBIT)
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.
Read the 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.
- Conditions
- Iron Deficiency Anemia (IDA)
- Being tested
- Directly observed home based daily iron therapy
- Keywords
- anemia, iron deficiency, nutritional, iron supplementation, cluster randomized control trial
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directly observed home based daily iron therapyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Directly observed home based daily iron therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anemia
Compare the prevalence of anemia in two cluster randomized groups of villages
Measured: 1 year
Secondary outcomes (1)
Compliance with iron therapy
To compare the degree of compliance with iron therapy by anemic women between two cluster randomized groups of villages
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia (IDA)Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Build Healthy India Movement
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, India
- Investigators
- Dr Sahul Bharti, MD Pediatrics, PDCC, Dip Stats, Principal investigator, Build Healthy India Movement (BHIM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129843
- Sponsor's protocol ID
- No.SSD/WS/102/2008
- Acronym
- DOHBIT
- Status last verified
- May 2011
- First submitted
- 22 May 2010
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15523164
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial for Lowering Prevalence of Anemia in Rural Hilly Villages With Directly Observed Home Based Daily Iron Therapy(DOHBIT)
- ClinicalTrials.gov ID
- NCT01129843
- Acronym / sponsor ID
- DOHBIT / No.SSD/WS/102/2008
- Conditions
- Iron Deficiency Anemia (IDA)
- Keywords
- anemia, iron deficiency, nutritional, iron supplementation, cluster randomized control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Build Healthy India MovementUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, India
- Study start
- May 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 25 May 2010 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Directly observed home based daily iron therapy | Experimental | Drug: Directly observed home based daily iron therapyVillage volunteers will provide directly observed home based daily iron supplementation( ferrous sulphate) to enrolled anemic women in the experimental arm |
| Clinic driven unsupervised daily iron therapy | Active comparator | Drug: Directly observed home based daily iron therapyIn the control group of villages, clinic driven unsupervised iron ( ferrous sulphate) supplementation will be offered on monthly basis to anemic women for 3 months |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women and adolescent girls aged 13 years and above who are diagnosed with anemia using WHO defined cut-offs for hemoglobin levels
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Directly observed home based daily iron therapyDirectly 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 | Drug | Clinic driven unsupervised daily iron therapy, Directly observed home based daily iron therapy |
Primary outcome
Prevalence of anemia
Time frame: 1 year
Compare the prevalence of anemia in two cluster randomized groups of villages
1 secondary outcome
Compliance with iron therapy
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
- Background: PubMed 15523164Bharti 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.
Related trials for Iron Deficiency Anemia (IDA)
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Recruiting
Alternate-Day vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
Iron Deficiency Anemia Treatment
RecruitingObservational study
Patient Blood Management in Patients Scheduled for Cardiac Surgery
Anemia, Anemia, Iron-Deficiency
RecruitingPhase 4
Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
Anemia, Iron Deficiency Anemia (IDA)
Not yet recruiting
Iron-Rich Snack Intervention for Anemia in Adolescent Girls
Iron Deficiency Anemia (IDA)
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.
Dr Sahul Bharti, MD Pediatrics, PDCC, Dip Stats principal investigator
Build Healthy India Movement (BHIM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Directly observed home based daily iron therapy in people with Iron Deficiency Anemia (IDA), run by Build Healthy India Movement at 1 site in India.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Jun 2011. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129843, which also lists 1 linked publication.
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 1 Jun 2011.