Celiac DiseaseNCT02949765
Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease
A study testing Iron sulfate 105 mg and Iron-rich diet in people with Celiac Disease and Iron Deficiency (Without Anemia), run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good compliance and clinical response to gluten-free diet. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Celiac Disease, Iron Deficiency (Without Anemia)
- What is being tested?
- Iron sulfate 105 mg and Iron-rich diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2015to Sep 2017
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Celiac patients on gluten free diet since 1 year
- iron deficiency (ferritin <15 ng/L or ferritin 15-20 + transferrin saturation <15%)
Who cannot join
- allergy to iron supplementation
- anemia
- pregnancy or breastfeeding
- menopause
- organic or psychiatric diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Milan, 20122
Francesca Ferretti, MD, 0039 0255033384, francesca.ferretti01@gmail.com
Luca Elli, MD, PhD
About this study
Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good compliance and clinical response to gluten-free diet. These patients are usually premenopausal women in whom the cyclic menstrual bleeding and the oral iron intake are not balanced.
The aim of the study is to compare the efficacy of a pharmacological therapy, frequently not tolerated, and a dietary approach through a iron-rich diet in this subset of patients.
- Conditions
- Celiac Disease, Iron Deficiency (Without Anemia)
- Being tested
- Iron sulfate 105 mg, Iron-rich diet
- Medical subject headings
- Celiac Disease, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron sulfate 105 mgDrug
Daily supplementation with iron sulfate 105 mg 1 pill/day
Iron-rich dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Iron sulfate 105 mg | Active comparator | Iron sulfate 105 mg: 1 pill/day is administered Receives: Drug: Iron sulfate 105 mg |
| Iron-rich diet | Experimental | Iron-rich diet recommendations are given Receives: Dietary Supplement: Iron-rich diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin levels (ng/mL) increase > 95% compared to basal levels
Measured: 12 weeks
Secondary outcomes (3)
Hemoglobin levels (g/dL), compared to basal levels
Measured: 12 weeks
Iron levels (mcd/dl), compared to basal levels
Measured: 12 weeks
Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Ferretti, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Francesca Francesca, MD, Principal investigator, Gastroenterology and Endoscopy Unit Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Department of Pathophysiology and Transplantation Università degli Studi di Milano - Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949765
- Sponsor's protocol ID
- Atto 302/2016
- Status last verified
- Mar 2017
- First submitted
- 21 Sep 2016
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease
- ClinicalTrials.gov ID
- NCT02949765
- Acronym / sponsor ID
- Atto 302/2016
- Conditions
- Celiac Disease, Iron Deficiency (Without Anemia)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 31 Oct 2016 (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.
Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good compliance and clinical response to gluten-free diet. These patients are usually premenopausal women in whom the cyclic menstrual bleeding and the oral iron intake are not balanced.
The aim of the study is to compare the efficacy of a pharmacological therapy, frequently not tolerated, and a dietary approach through a iron-rich diet in this subset of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron sulfate 105 mg | Active comparator | Drug: Iron sulfate 105 mgIron sulfate 105 mg: 1 pill/day is administered |
| Iron-rich diet | Experimental | Dietary Supplement: Iron-rich dietIron-rich diet recommendations are given |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Celiac patients on gluten free diet since 1 year
- iron deficiency (ferritin <15 ng/L or ferritin 15-20 + transferrin saturation <15%)
Key exclusion criteria (5 listed)
- allergy to iron supplementation
- anemia
- pregnancy or breastfeeding
- menopause
- organic or psychiatric diseases
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 sulfate 105 mgDaily supplementation with iron sulfate 105 mg 1 pill/day | Drug | Iron sulfate 105 mg |
| Iron-rich diet | Dietary supplement | Iron-rich diet |
Primary outcome
Ferritin levels (ng/mL) increase > 95% compared to basal levels
Time frame: 12 weeks
3 secondary outcomes
Hemoglobin levels (g/dL), compared to basal levels
Time frame: 12 weeks
Iron levels (mcd/dl), compared to basal levels
Time frame: 12 weeks
Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Francesca Francesca, MD principal investigator
Gastroenterology and Endoscopy Unit Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Department of Pathophysiology and Transplantation Università degli Studi di Milano - Italy.
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 sulfate 105 mg and Iron-rich diet in people with Celiac Disease and Iron Deficiency (Without Anemia), run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 5 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 14 Mar 2017. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca Ferretti, MD (0039 0255033384, francesca.ferretti01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferritin levels (ng/mL) increase > 95% compared to basal levels (time frame: 12 weeks). 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 14 Mar 2017.