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OpenTrials
Completed

NCT Number: NCT01874496

Iron Absorption From GDS Capsules

Slow release iron capsules have been designed based on the gastric delivery system. Iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes.

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Laboratory, ETH Zurich

Zurich, Canton of Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female,
  • age 18-50 years,
  • max. body weight 65 kg,
  • serum ferritin < 35µg/l

Exclusion criteria

  • pregnancy,
  • lactation,
  • regular intake of medication,
  • blood donation or significant blood losses over the past 4 months

Treatment and study plan

GDS, no meal

Dietary Supplement

GDS, no meal

GDS, meal

Dietary Supplement

GDS, meal

control, no meal

Dietary Supplement

control, no meal

control, meal

Dietary Supplement

control, meal

Primary outcomes

  1. fractional iron absorption

    Time frame: 2, 4, 6, and 8 weeks

Secondary outcomes

  1. serum isotope appearance

    Time frame: day 1, 15, 29 and 33

Other outcomes

  1. Serum non transferrin bound iron

    Time frame: day 1, 15, 29 and 33

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

Iron Absorption Mechanism From a Slow Release Iron Capsule Using the Gastric Delivery System

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2013
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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