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

NCT03191201 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-03-26

No results posted yet for this study

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.

Conditions

  • Iron-deficiency
  • Iron Toxicity
  • Glucose Metabolism Disorders (Including Diabetes Mellitus)
  • Metabolic Side Effects of Drugs
  • Metabolic Disorder, Glucose
  • Safety Issues

Interventions

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.

DRUG

0.9% sodium chloride solution

250 mL of a commercially available sterile 0.9% sodium chloride solution.

Sponsors & Collaborators

  • Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

    collaborator OTHER

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • University of Lausanne

    collaborator OTHER

  • Prof Gérard WAEBER

    lead OTHER

Principal Investigators

  • Gérard Waeber, MD · Centre Hospitalier Universitaire Vaudois (CHUV)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-21
Primary Completion
2020-03-09
Completion
2020-03-09

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03191201 on ClinicalTrials.gov