Iron Absorption From GDS Capsules

Iron Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874496
• Other study ID #: EK 2013-N-05
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: September 12, 2013
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethical committee ETH Zurich
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• GDS, no meal
GDS, no meal
• GDS, meal
GDS, meal
• control, no meal
control, no meal
• control, meal
control, meal

Locations

Country	Name	City	State
Switzerland	Human Nutrition Laboratory, ETH Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum non transferrin bound iron		day 1, 15, 29 and 33	No
Primary	fractional iron absorption		2, 4, 6, and 8 weeks	No
Secondary	serum isotope appearance		day 1, 15, 29 and 33	No