Iron Deficiency AnemiaPhase 2FISRANCT02037724
Fermented Iron-rich Supplement in Reducing Anemia
A Phase 2 study testing supplement containing 60 mg iron sulfate, iron rich food supplement (60 mg iron) and iron rich food supplement (10 mg iron) in people with Iron Deficiency Anemia, run by University of Ghana.
Trial summary
The consequences of iron deficiency anemia in women are enormous, and especially in developing countries, as the condition adversely affects both their productive and reproductive capabilities. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- supplement containing 60 mg iron sulfate, iron rich food supplement (60 mg iron) and iron rich food supplement (10 mg iron)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Oct 2014
- Phase
- Phase 2
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-49 years
- Regular menstruation in the last three months
- Hemoglobin <12 mg/dl;
- Serum Ferittin<20mcg/L
- BMI 18.5Kg/m^2 to 29.9 kg/m^2
Who cannot join
- history of gastrointestinal or hematological disorders,
- taking medications that could interfere with hematopoiesis or dietary iron absorption
- pregnant (based on pregnancy test).
Trial locations and contacts
No sites are listed yet.
About this study
The consequences of iron deficiency anemia in women are enormous, and especially in developing countries, as the condition adversely affects both their productive and reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators among women receiving an iron-rich organic food supplement versus ferrous sulfate supplement, and 2) determine the suitable level of food supplement needed to prevent/reduce iron deficiency anemia among women in developing country settings.
A double-blind, randomized, controlled, intervention trial will be implemented in women of childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency. After screening potential subjects (up to 500 expected), approximately 30 will be recruited into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in ferritin as significant between the two time points at 80% power and alpha value of 0.05. Subjects who meet the inclusion criteria will be randomized into the four groups consisting of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8 weeks while subjects taking FS-10 and IRS-10 will take the supplement under supervision for 12 consecutive weeks.
Read the detailed description
The design will involve screening of about 500 female adult students and staff of the University of Ghana who meet initial the inclusion criteria. Screening will involve pregnancy testing, assessment of hemoglobin, and ferritin and also administration of a health history questionnaire.
Thereafter, 120 eligible subjects will enrolled and randomized to recieve the treatment. All subjects will complete 3-day dietary record (including 2 weekdays and 1 weekend) at baseline and at endline (i.e. one week prior to treatment completion). The dietary data will be analyzed using nationally-generated food composition tables together with the ESHA food processor software. In addition, body weight and height will be measured using standard methods at baseline and end of the study. Weekly monitoring of side effects will be recorded. Fasting blood samples will be collected at baseline and endline to enable determination of anemia status and other indicators including serum ferritin, transferrin receptor and full blood count, together with C-reactive protein.
- Conditions
- Iron Deficiency Anemia
- Being tested
- supplement containing 60 mg iron sulfate, iron rich food supplement (60 mg iron), iron rich food supplement (10 mg iron), supplement containing 10 mg iron sulfate
- 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.
supplement containing 60 mg iron sulfateDietary supplement
control agent
iron rich food supplement (60 mg iron)Dietary supplement
contains 60 mg of iron
iron rich food supplement (10 mg iron)Dietary supplement
contains 10 mg iron
supplement containing 10 mg iron sulfateDietary supplement
control agent
| Study group | Role | What they receive |
|---|---|---|
| supplement containing 60 mg iron sulfate | Other | nutrient supplement containing 60 mg of iron as ferous sulfate Receives: Dietary Supplement: iron rich food supplement (60 mg iron); Dietary Supplement: iron rich food supplement (10 mg iron); Dietary Supplement: supplement containing 10 mg iron sulfate |
| iron rich food supplement (60 mg iron) | Experimental | contains 60 mg Iron Receives: Dietary Supplement: supplement containing 60 mg iron sulfate; Dietary Supplement: iron rich food supplement (10 mg iron); Dietary Supplement: supplement containing 10 mg iron sulfate |
| iron rich food supplement (10 mg iron) | Experimental | contains 10 mg of iron Receives: Dietary Supplement: supplement containing 60 mg iron sulfate; Dietary Supplement: iron rich food supplement (60 mg iron); Dietary Supplement: supplement containing 10 mg iron sulfate |
| supplement containing 10 mg iron sulfate | Other | nutrient supplement containing 10 mg of iron as ferous sulfate Receives: Dietary Supplement: supplement containing 60 mg iron sulfate; Dietary Supplement: iron rich food supplement (60 mg iron); Dietary Supplement: iron rich food supplement (10 mg iron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
iron deficiency anemia
Improvement of iron status with 60 mg (after two months) and 10 mg iron (after 3 months) will be assessed. The iron status measurements include, hemoglobin, ferritin, transferrin receptor and whole blood count
Measured: two and three months
Secondary outcomes (1)
comparison of side effects of iron supplement
We expect to have less side effects with IRS compared with ferrous sulfate (as observed in previous studies) that include: constipation, diarrhea, vomiting, gastrointestinal distress, change in stool color and others. We will assess these with a questionnaire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014 (estimated)
- Study completionOct 2014 (estimated)
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ghana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richmond Aryeetey, PhD, MPH, University of Ghana
- Investigators
- Richmond Aryeetey, PhD, Principal investigator, University of GhanaManju Reddy, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037724
- Sponsor's protocol ID
- UG-0001-IDA
- Acronym
- FISRA
- Status last verified
- Jan 2014
- First submitted
- 14 Jan 2014
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fermented Iron-rich Supplement in Reducing Anemia
- ClinicalTrials.gov ID
- NCT02037724
- Acronym / sponsor ID
- FISRA / UG-0001-IDA
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of GhanaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 16 Jan 2014 (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.
The consequences of iron deficiency anemia in women are enormous, and especially in developing countries, as the condition adversely affects both their productive and reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators among women receiving an iron-rich organic food supplement versus ferrous sulfate supplement, and 2) determine the suitable level of food supplement needed to prevent/reduce iron deficiency anemia among women in developing country settings.
A double-blind, randomized, controlled, intervention trial will be implemented in women of childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency. After screening potential subjects (up to 500 expected), approximately 30 will be recruited into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in ferritin as significant between the two time points at 80% power and alpha value of 0.05. Subjects who meet the inclusion criteria will be randomized into the four groups consisting of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8 weeks while subjects taking FS-10 and IRS-10 will take the supplement under supervision for 12 consecutive weeks.
Detailed description
The design will involve screening of about 500 female adult students and staff of the University of Ghana who meet initial the inclusion criteria. Screening will involve pregnancy testing, assessment of hemoglobin, and ferritin and also administration of a health history questionnaire.
Thereafter, 120 eligible subjects will enrolled and randomized to recieve the treatment. All subjects will complete 3-day dietary record (including 2 weekdays and 1 weekend) at baseline and at endline (i.e. one week prior to treatment completion). The dietary data will be analyzed using nationally-generated food composition tables together with the ESHA food processor software. In addition, body weight and height will be measured using standard methods at baseline and end of the study. Weekly monitoring of side effects will be recorded. Fasting blood samples will be collected at baseline and endline to enable determination of anemia status and other indicators including serum ferritin, transferrin receptor and full blood count, together with C-reactive protein.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| supplement containing 60 mg iron sulfate | Other | Dietary Supplement: iron rich food supplement (60 mg iron), Dietary Supplement: iron rich food supplement (10 mg iron), Dietary Supplement: supplement containing 10 mg iron sulfatenutrient supplement containing 60 mg of iron as ferous sulfate |
| iron rich food supplement (60 mg iron) | Experimental | Dietary Supplement: supplement containing 60 mg iron sulfate, Dietary Supplement: iron rich food supplement (10 mg iron), Dietary Supplement: supplement containing 10 mg iron sulfatecontains 60 mg Iron |
| iron rich food supplement (10 mg iron) | Experimental | Dietary Supplement: supplement containing 60 mg iron sulfate, Dietary Supplement: iron rich food supplement (60 mg iron), Dietary Supplement: supplement containing 10 mg iron sulfatecontains 10 mg of iron |
| supplement containing 10 mg iron sulfate | Other | Dietary Supplement: supplement containing 60 mg iron sulfate, Dietary Supplement: iron rich food supplement (60 mg iron), Dietary Supplement: iron rich food supplement (10 mg iron)nutrient supplement containing 10 mg of iron as ferous sulfate |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-49 years
- Regular menstruation in the last three months
- Hemoglobin <12 mg/dl;
- Serum Ferittin<20mcg/L
- BMI 18.5Kg/m^2 to 29.9 kg/m^2
Key exclusion criteria (3 listed)
- history of gastrointestinal or hematological disorders,
- taking medications that could interfere with hematopoiesis or dietary iron absorption
- pregnant (based on pregnancy test).
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 |
|---|---|---|
| supplement containing 60 mg iron sulfatecontrol agent | Dietary supplement | iron rich food supplement (10 mg iron), iron rich food supplement (60 mg iron), supplement containing 10 mg iron sulfate |
| iron rich food supplement (60 mg iron)contains 60 mg of iron | Dietary supplement | iron rich food supplement (10 mg iron), supplement containing 10 mg iron sulfate, supplement containing 60 mg iron sulfate |
| iron rich food supplement (10 mg iron)contains 10 mg iron | Dietary supplement | iron rich food supplement (60 mg iron), supplement containing 10 mg iron sulfate, supplement containing 60 mg iron sulfate |
| supplement containing 10 mg iron sulfatecontrol agent | Dietary supplement | iron rich food supplement (10 mg iron), iron rich food supplement (60 mg iron), supplement containing 60 mg iron sulfate |
Primary outcome
iron deficiency anemia
Time frame: two and three months
Improvement of iron status with 60 mg (after two months) and 10 mg iron (after 3 months) will be assessed. The iron status measurements include, hemoglobin, ferritin, transferrin receptor and whole blood count
1 secondary outcome
comparison of side effects of iron supplement
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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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.
Richmond Aryeetey, PhD principal investigator
University of Ghana
Manju Reddy, PhD principal investigator
Iowa State University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing supplement containing 60 mg iron sulfate, iron rich food supplement (60 mg iron) and iron rich food supplement (10 mg iron) in people with Iron Deficiency Anemia, run by University of Ghana.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richmond Aryeetey, PhD (233244129669, raryeetey@ug.edu.gh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iron deficiency anemia (time frame: two and three months). 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 16 Jan 2014; AzTrials last refreshed its copy on 3 Nov 2026.