NCT03191201

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

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.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Prof Gérard WAEBER · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-06-21
• Primary completion: 2020-03-09
• Completion: 2020-03-09
• First posted: 2017-06-19
• Last updated: 2020-03-26

Locations

1 site across 1 country: Switzerland