Safety Issues Clinical Trial
— DIAFEROfficial 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.
Verified date | March 2020 |
Source | University of Lausanne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Switzerland | Policlinique Médicale Universitaire | Lausanne | Vaud |
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 |
Switzerland,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04485481 -
Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT03473236 -
Phase 1A Safety Trial of Inhaled PK10571 (GB002)
|
Phase 1 | |
Not yet recruiting |
NCT03683953 -
The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
|
Phase 1 | |
Recruiting |
NCT05546567 -
NOPARK Open Label Extension Study
|
N/A | |
Recruiting |
NCT05413226 -
Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility
|
N/A | |
Recruiting |
NCT05112159 -
Study of IPG1094 in Healthy Participants
|
Phase 1 | |
Completed |
NCT04689035 -
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
|
Phase 1 | |
Completed |
NCT04335045 -
Phase I Study of PH100 (Ecklonia Cava Phlorotannins)
|
Phase 1 | |
Completed |
NCT05037227 -
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
|
||
Recruiting |
NCT05517291 -
DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
|
N/A | |
Enrolling by invitation |
NCT06446778 -
Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms
|
||
Recruiting |
NCT04573049 -
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
|
Phase 4 | |
Completed |
NCT05585463 -
Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
|
||
Completed |
NCT04188821 -
Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander
|
N/A | |
Completed |
NCT03667430 -
Safety Evaluation of Porous Silica in Men
|
N/A | |
Completed |
NCT04499482 -
Safety and Tolerability of Soy Fiber
|
N/A | |
Completed |
NCT03141905 -
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
|
N/A | |
Completed |
NCT05244161 -
A Quasi-experimental Evaluation of the Malezi Program in Tanzania
|
N/A | |
Recruiting |
NCT03791372 -
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
|
Phase 1 | |
Not yet recruiting |
NCT04774900 -
Standardization of Ambulance Equipment
|