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OpenTrials
Completed

NCT Number: NCT01985386

Iron Absorption From GDS Capsules II

Slow release iron capsules containing ferrous sulfate 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, 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 < 30 µg/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 capsule with meal

Dietary Supplement

GDS capsule with meal

Ferrous sulfate with meal

Dietary Supplement

Ferrous sulfate with meal

Primary outcomes

  1. Fractional iron absorption

    Time frame: 2 weeks after test meal consumption

Secondary outcomes

  1. Serum isotope appearance

    Time frame: 1, 2, 4 and 8 hours on days 1 and 8

Other outcomes

  1. Serum non transferrin bound iron

    Time frame: 1, 2, 4 and 8 hours on days 1 and 8

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 (Ferrous Sulfate)

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 15, 2013
Registry last updated
Jul 30, 2014

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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