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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03191201
Other study ID # 2016-01449
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date June 21, 2017
Est. completion date March 9, 2020

Study information

Verified date March 2020
Source University of Lausanne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, parameters related to metabolic syndrome and inflammation will be measured before and after the intervention.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date March 9, 2020
Est. primary completion date March 9, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ferric Carboxymaltose
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 solution
250 mL of a commercially available sterile 0.9% sodium chloride solution.

Locations

Country Name City State
Switzerland Policlinique Médicale Universitaire Lausanne Vaud

Sponsors (4)

Lead Sponsor Collaborator
Prof Gérard WAEBER Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, Centre Hospitalier Universitaire Vaudois, University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline in the plasma metabolomic profiling as assessed by metabolomics Metabolomics at 14 and 28 days of the injection of the Investigation Product
Other Change from baseline in circulating miRNAs selected miRNA as measured by qPCR at 14 and 28 days of the injection of the Investigation Product
Primary Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation. two-step hyperglycaemic clamp investigation at 28 days of the injection of the Investigation Product
Secondary Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 14 days plasma hs-CRP levels at 14 days of the injection of the Investigation Product
Secondary Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 28 days plasma hs-CRP levels at 28 days of the injection of the Investigation Product
Secondary Change from baseline in interleukin-6 (IL-6) levels at 14 days plasam IL-6 levels at 14 days of the injection of the Investigation Product
Secondary Change from baseline in interleukin-6 (IL-6) levels at 28 days plasam IL-6 levels at 28 days of the injection of the Investigation Product
Secondary Change from baseline in adiponectin levels at 14 days adiponectin at 14 days of the injection of the Investigation Product
Secondary Change from baseline in adiponectin levels at 28 days adiponectin at 28 days of the injection of the Investigation Product
Secondary Change from baseline in interleukin-1beta levels at 14 days IL-1b at 14 days of the injection of the Investigation Product
Secondary Change from baseline in interleukin-1beta levels at 28 days IL-1b at 28 days of the injection of the Investigation Product
Secondary Change from baseline in blood pressure levels at 14 days systolic and diastolic blood pressure at 14 days of the injection of the Investigation Product
Secondary Change from baseline in blood pressure levels at 28 days systolic and diastolic blood pressure at 28 days of the injection of the Investigation Product
Secondary Change from baseline in the plasma lipid profile level at 14 days plasma total- and HDL-cholesterol and plasam triglycerides at 14 days of the injection of the Investigation Product
Secondary Change from baseline in the plasma lipid profile level at 28 days plasma total- and HDL-cholesterol and plasam triglycerides at 28 days of the injection of the Investigation Product
Secondary Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 14 days Calculated Homeostasis Model Assessment (HOMA-2) index at 14 days of the injection of the Investigation Product
Secondary Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 28 days Calculated Homeostasis Model Assessment (HOMA-2) index at 28 days of the injection of the Investigation Product
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