A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucos… (NCT03191201) | Clinical Trial Compass
TerminatedPhase 4
A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.
Stopped: The reason for early termination is difficulties recruiting that caused a premature ending of financial resources ensuring protected time for research.
Switzerland32 participantsStarted 2017-06-21
Plain-language 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, parameters related to metabolic syndrome and inflammation will be measured before and after the intervention.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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.
Exclusion Criteria:
* 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.
* Blood transfusion within the last 12 weeks.
* Intake of iron preparations 4 weeks prior to screening.
* Known hypersensitivity to FCM or to any…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation.
Timeframe: at 28 days of the injection of the Investigation Product