Iron-deficiencyPhase 4DIAFERNCT03191201

A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.

A Phase 4 study testing Ferric Carboxymaltose and 0.9% sodium chloride solution in people with Iron-deficiency and Iron Toxicity, run by Prof Gérard WAEBER at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

In this study the investigators aim at addressing potential relationships between iron stores and glucose homeostasis. Iron (i.e. Ferric Carboxymaltose) will be perfused to pre-menopausal, iron-deficient non-anaemic women suffering from a chronic fatigue syndrome and parameters related to glucose homeostasis… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Iron-deficiency, Iron Toxicity, Glucose Metabolism Disorders (Including Diabetes Mellitus)
What is being tested?: Ferric Carboxymaltose and 0.9% sodium chloride solution
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteSwitzerland
Study dates: 21 Jun 2017to 9 Mar 2020
Phase: Phase 4
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Premenopausal women.
Negative pregnancy test.
Adequate contraception during the study period and for 1 month following study completion.
Overt or relative iron deficiency at screening defined as follows:
Serum ferritin <50 ng/mL AND transferrin saturation <20%, OR Serum ferritin <30 ng/mL.
Serum C-reactive protein: <5 mg/L if not on oral contraception, OR <20 mg/L if use of oral contraception

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Intolerance to oral iron formulations, or lack of efficacy of oral iron formulations.
Minimum total score of 5 on the Visual analogic scale of fatigue.
Normal levels of vitamin B12 and folic acid at screening.
Availability and willingness to complete all study visits and procedures per protocol.
Ability to sign an informed consent.

Who cannot join

Age <18 years.
Menopause (defined as an amenorrhea of at least 12 months).
Irregularly menstruating women (menstrual cycle outside a range of 24-38 days in duration) or experiencing overt metrorrhagia (simple spotting not being an exclusion criteria).
Body mass index <18.5 kg/m2 or >30 kg/m2.
Diabetes, defined as subjects with HbA1c ≥ 6.5 % and/or with fasting blood glucose levels ≥ 7 mmol/l and/or with a history of diabetes and/or by the use of anti-diabetic drugs.
Hb level <117 g/L or known haemoglobinopathy or haemochromatosis.

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Blood transfusion within the last 12 weeks.
Intake of iron preparations 4 weeks prior to screening.
Known hypersensitivity to FCM or to any other iron preparation.
Suspicion of major depressive disorder based on Patient Health Questionnaire.
Known chronic inflammatory disease, including human immunodeficiency virus, hepatitis B or hepatitis C virus infection.
Active malignancy.
Decreased renal function (estimated glomerular filtration rate using the CKD-EPI equation<60 ml/min/1.73m2).
Liver dysfunction (aspartate aminotransferase and alanine aminotransferase > 3-fold upper limit).
Angina (Class IV).
Asthma.
Documented sleep apnoea.
Important recent weight loss (>10% within the past month).
Thyroid dysfunction (thyroid stimulating hormone >4 µU/mL).
Reported weekly alcohol consumption > 14 standard drinks.
Drug abuse (any drug consumption reported in the past 12 months).

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Policlinique Médicale Universitaire
Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: A Double Blind Randomised Placebo-controlled Trial to Assess the Effect of a Single Administration of Ferric Carboxymaltose of 1000 mg Iron on Glucose Homeostasis, in Iron-deficient Non-anaemic Women of Childbearing Age.

Conditions: Iron-deficiency, Iron Toxicity, Glucose Metabolism Disorders (Including Diabetes Mellitus), Metabolic Side Effects of Drugs, Metabolic Disorder, Glucose, Safety Issues
Being tested: Ferric Carboxymaltose, 0.9% sodium chloride solution
Keywords: Metabolomics, Transcriptomics, Ironomics
Medical subject headings: Anemia, Iron-Deficiency, Glucose Metabolism Disorders, Metabolic Side Effects of Drugs and Substances

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ferric CarboxymaltoseDrug
Ferric Carboxymaltose 1000 mg iron element will be diluted in 250 mL of a commercially available sterile 0.9% sodium chloride solution.
0.9% sodium chloride solutionDrug
250 mL of a commercially available sterile 0.9% sodium chloride solution.

Study groups in NCT03191201
Study group	Role	What they receive
Ferric carboxymaltose arm	Active comparator	Ferric carboxymaltose (FCM), 1000 mg iron element will be administered once by drip infusion (Intravenous route). FCM will be diluted in 250 mL of a commercially available sterile 0.9% sodium chloride solution prior to administration. Infusion time will be 15 minutes. Receives: Drug: Ferric Carboxymaltose
Placebo arm	Placebo comparator	A commercially available sterile, 250 mL, 0.9% sodium chloride solution will be administered by drip infusion (Intravenous route). Infusion time will be 15 minutes. At the end of the randomised part of the study, participants initially randomised to the placebo group will be included in a non-blinded open-label extension part and receive a FCM 1000 mg injection. Receives: Drug: 0.9% sodium chloride solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation.
two-step hyperglycaemic clamp investigation
Measured: at 28 days of the injection of the Investigation Product

Secondary outcomes (14)

Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 14 days
plasma hs-CRP levels
Measured: at 14 days of the injection of the Investigation Product
Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 28 days
plasma hs-CRP levels
Measured: at 28 days of the injection of the Investigation Product
Change from baseline in interleukin-6 (IL-6) levels at 14 days
plasam IL-6 levels
Measured: at 14 days of the injection of the Investigation Product
Change from baseline in interleukin-6 (IL-6) levels at 28 days
plasam IL-6 levels
Measured: at 28 days of the injection of the Investigation Product
Change from baseline in adiponectin levels at 14 days
adiponectin
Measured: at 14 days of the injection of the Investigation Product
Change from baseline in adiponectin levels at 28 days
adiponectin
Measured: at 28 days of the injection of the Investigation Product
Change from baseline in interleukin-1beta levels at 14 days
IL-1b
Measured: at 14 days of the injection of the Investigation Product
Change from baseline in interleukin-1beta levels at 28 days
IL-1b
Measured: at 28 days of the injection of the Investigation Product
Change from baseline in blood pressure levels at 14 days
systolic and diastolic blood pressure
Measured: at 14 days of the injection of the Investigation Product
Change from baseline in blood pressure levels at 28 days
systolic and diastolic blood pressure
Measured: at 28 days of the injection of the Investigation Product
Change from baseline in the plasma lipid profile level at 14 days
plasma total- and HDL-cholesterol and plasam triglycerides
Measured: at 14 days of the injection of the Investigation Product
Change from baseline in the plasma lipid profile level at 28 days
plasma total- and HDL-cholesterol and plasam triglycerides
Measured: at 28 days of the injection of the Investigation Product
Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 14 days
Calculated Homeostasis Model Assessment (HOMA-2) index
Measured: at 14 days of the injection of the Investigation Product
Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 28 days
Calculated Homeostasis Model Assessment (HOMA-2) index
Measured: at 28 days of the injection of the Investigation Product

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 20179 Mar 2020

First posted19 Jun 2017
Study start21 Jun 2017
Primary completion9 Mar 2020
Study completion9 Mar 2020

Why it stopped: The reason for early termination is difficulties recruiting that caused a premature ending of financial resources ensuring protected time for research.

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-deficiencyStudies 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double blind randomised placebo-controlled, parallel group comparative inferiority study with open-label extension divided in two parts: * A first randomised and double-blind part in which FCM or placebo will be administered at baseline and post-baseline parameters assessed. * A second non-randomised, non-blinded open-label extension part starting at the end of part 1, in which participants randomised to the placebo group will receive a FCM injection and post-baseline parameters assessed.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03191201
Sponsor's protocol ID: 2016-01449
Other IDs: 2016
Acronym: DIAFER
Status last verified: Mar 2020
First submitted: 17 May 2017
Last updated: 26 Mar 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jaccard E, Seyssel K, Gouveia A, Vergely C, Baratali L, Gubelmann C, Froissart M, Favrat B, Marques-Vidal P, Tappy L, Waeber G. Effect of acute iron infusion on insulin secretion: A randomized, double-blind, placebo-controlled trial. EClinicalMedicine. 2022 May 6;48:101434. doi: 10.1016/j.eclinm.2022.101434. eCollection 2022 Jun.
PubMed 35706490

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Iron-deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double Blind Randomised Placebo-controlled Trial to Assess the Effect of a Single Administration of Ferric Carboxymaltose of 1000 mg Iron on Glucose Homeostasis, in Iron-deficient Non-anaemic Women of Childbearing Age.
ClinicalTrials.gov ID: NCT03191201
Acronym / sponsor ID: DIAFER / 2016-01449
Conditions: Iron-deficiency, Iron Toxicity, Glucose Metabolism Disorders (Including Diabetes Mellitus), Metabolic Side Effects of Drugs, Metabolic Disorder, Glucose, Safety Issues
Keywords: Metabolomics, Transcriptomics, Ironomics
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The reason for early termination is difficulties recruiting that caused a premature ending of financial resources ensuring protected time for research.
Enrolment: 32 participants (actual)
Lead sponsor: Prof Gérard WAEBERUniversity, hospital or other
Collaborators: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, Centre Hospitalier Universitaire Vaudois, University of Lausanne
Study start: 21 Jun 2017 (actual)
Primary completion: 9 Mar 2020 (actual)
Study completion: 9 Mar 2020 (actual)
First posted: 19 Jun 2017 (actual)
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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Double blind randomised placebo-controlled, parallel group comparative inferiority study with open-label extension divided in two parts: * A first randomised and double-blind part in which FCM or placebo will be administered at baseline and post-baseline parameters assessed. * A second non-randomised, non-blinded open-label extension part starting at the end of part 1, in which participants randomised to the placebo group will receive a FCM injection and post-baseline parameters assessed.

Arm	Type	Receives
Ferric carboxymaltose arm	Active comparator	Drug: Ferric CarboxymaltoseFerric carboxymaltose (FCM), 1000 mg iron element will be administered once by drip infusion (Intravenous route). FCM will be diluted in 250 mL of a commercially available sterile 0.9% sodium chloride solution prior to administration. Infusion time will be 15 minutes.
Placebo arm	Placebo comparator	Drug: 0.9% sodium chloride solutionA commercially available sterile, 250 mL, 0.9% sodium chloride solution will be administered by drip infusion (Intravenous route). Infusion time will be 15 minutes. At the end of the randomised part of the study, participants initially randomised to the placebo group will be included in a non-blinded open-label extension part and receive a FCM 1000 mg injection.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Premenopausal women.
Negative pregnancy test.
Adequate contraception during the study period and for 1 month following study completion.
Overt or relative iron deficiency at screening defined as follows:
Serum ferritin <50 ng/mL AND transferrin saturation <20%, OR Serum ferritin <30 ng/mL.

Key exclusion criteria (21 listed)

Age <18 years.
Menopause (defined as an amenorrhea of at least 12 months).
Irregularly menstruating women (menstrual cycle outside a range of 24-38 days in duration) or experiencing overt metrorrhagia (simple spotting not being an exclusion criteria).
Body mass index <18.5 kg/m2 or >30 kg/m2.
Diabetes, defined as subjects with HbA1c ≥ 6.5 % and/or with fasting blood glucose levels ≥ 7 mmol/l and/or with a history of diabetes and/or by the use of anti-diabetic drugs.

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
Ferric CarboxymaltoseFerric Carboxymaltose 1000 mg iron element will be diluted in 250 mL of a commercially available sterile 0.9% sodium chloride solution.	Drug	Ferric carboxymaltose arm
0.9% sodium chloride solution250 mL of a commercially available sterile 0.9% sodium chloride solution.	Drug	Placebo arm

Primary outcome

Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation.
Time frame: at 28 days of the injection of the Investigation Product
two-step hyperglycaemic clamp investigation

14 secondary outcomes

Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 14 days
Time frame: at 14 days of the injection of the Investigation Product
Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 28 days
Time frame: at 28 days of the injection of the Investigation Product
Change from baseline in interleukin-6 (IL-6) levels at 14 days
Time frame: at 14 days of the injection of the Investigation Product
Change from baseline in interleukin-6 (IL-6) levels at 28 days
Time frame: at 28 days of the injection of the Investigation Product
Change from baseline in adiponectin levels at 14 days
Time frame: at 14 days of the injection of the Investigation Product
Change from baseline in adiponectin levels at 28 days
Time frame: at 28 days of the injection of the Investigation Product
Change from baseline in interleukin-1beta levels at 14 days
Time frame: at 14 days of the injection of the Investigation Product
Change from baseline in interleukin-1beta levels at 28 days
Time frame: at 28 days of the injection of the Investigation Product
Change from baseline in blood pressure levels at 14 days
Time frame: at 14 days of the injection of the Investigation Product
Change from baseline in blood pressure levels at 28 days
Time frame: at 28 days of the injection of the Investigation Product
Change from baseline in the plasma lipid profile level at 14 days
Time frame: at 14 days of the injection of the Investigation Product
Change from baseline in the plasma lipid profile level at 28 days
Time frame: at 28 days of the injection of the Investigation Product
Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 14 days
Time frame: at 14 days of the injection of the Investigation Product
Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 28 days
Time frame: at 28 days of the injection of the Investigation Product

Results and safety

The study was stopped early (reason given: The reason for early termination is difficulties recruiting that caused a premature ending of financial resources ensuring protected time for research.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
Derived from this study: PubMed 35706490Jaccard E, Seyssel K, Gouveia A, Vergely C, Baratali L, Gubelmann C, Froissart M, Favrat B, Marques-Vidal P, Tappy L, Waeber G. Effect of acute iron infusion on insulin secretion: A randomized, double-blind, placebo-controlled trial. EClinicalMedicine. 2022 May 6;48:101434. doi: 10.1016/j.eclinm.2022.101434. eCollection 2022 Jun.
Individual participant dataSharing planned: No

Related trials for Iron-deficiency

Active, not recruiting
A Study to Evaluate the Effects of a Beef Liver Supplement on Energy, Mood, and Mental Clarity
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Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
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Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
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Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
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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.

Gérard Waeber, MD study director

Centre hospitalier universitaire vaudois (CHUV)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ferric Carboxymaltose and 0.9% sodium chloride solution in people with Iron-deficiency and Iron Toxicity, run by Prof Gérard WAEBER at 1 site in Switzerland.

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 11 inclusion and 21 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: stopped early, as of the sponsor's last update on 26 Mar 2020. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation. (time frame: at 28 days of the injection of the Investigation Product). 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 NCT03191201, 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 26 Mar 2020.