Iron Deficiency AnemiaNCT00198848
Iron Supplementation Among Adolescent Girls in India
A study testing Iron-folic acid supplement in people with Iron Deficiency Anemia, run by Johns Hopkins Bloomberg School of Public Health at 1 site in India.
Trial summary
This study will implement and evaluate a community-based intervention to distribute and promote consumption of weekly iron-folic acid supplements and to provide nutrition education to reduce the prevalence of iron deficiency anemia among adolescent girls in West Bengal, India. Read more about this study
- Who is it for?
- Ages 12 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Iron-folic acid supplement
- How many people
- 2,800 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2005to Jul 2007
- 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 12 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Girl 12-19 years of age
- Resides in study area
Who cannot join
- Does not reside in study area
Trial locations and contacts
1 site in 1 country.
About this study
This study will implement and evaluate a community-based intervention to distribute and promote consumption of weekly iron-folic acid supplements and to provide nutrition education to reduce the prevalence of iron deficiency anemia among adolescent girls in West Bengal, India.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Iron-folic acid supplement
- Keywords
- Iron deficiency anemia, Adolescent girls, India
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron-folic acid supplementDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anemia after 1 year of intervention
Secondary outcomes (5)
Knowledge of anemia
Practices regarding treatment and prevention of anemia
Knowledge of iron supplements
Practices regarding iron supplements
Dietary iron intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Michele L Dreyfuss, PhD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198848
- Sponsor's protocol ID
- H.32.04.11.22.A2
- Other IDs
- S3433-23/23 (ASPH)
- Status last verified
- Jan 2006
- First submitted
- 13 Sep 2005
- Last updated
- 20 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Supplementation Among Adolescent Girls in India
- ClinicalTrials.gov ID
- NCT00198848
- Acronym / sponsor ID
- H.32.04.11.22.A2
- Conditions
- Iron Deficiency Anemia
- Keywords
- Iron deficiency anemia, Adolescent girls, India
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Sep 2005 (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.
This study will implement and evaluate a community-based intervention to distribute and promote consumption of weekly iron-folic acid supplements and to provide nutrition education to reduce the prevalence of iron deficiency anemia among adolescent girls in West Bengal, India.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Girl 12-19 years of age
- Resides in study area
Key exclusion criteria (1 listed)
- Does not reside in study area
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 |
|---|---|---|
| Iron-folic acid supplement | Drug | – |
Primary outcome
Prevalence of anemia after 1 year of intervention
5 secondary outcomes
Knowledge of anemia
Practices regarding treatment and prevention of anemia
Knowledge of iron supplements
Practices regarding iron supplements
Dietary iron intake
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 20 Apr 2018.
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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.
Michele L Dreyfuss, PhD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron-folic acid supplement in people with Iron Deficiency Anemia, run by Johns Hopkins Bloomberg School of Public Health 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 2 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 20 Apr 2018. 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 after 1 year of intervention. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2018.