Iron Absorption From GDS Capsules II

Iron Deficiency Clinical Trial

Official title:

Iron Absorption Mechanism From a Slow Release Iron Capsule Using the Gastric Delivery System (Ferrous Sulfate)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985386
• Other study ID #: EK 2013-N-05-2
• Status: Completed
• Phase: N/A
• First received: October 31, 2013
• Last updated: July 29, 2014
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2014
• Est. primary completion date: December 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 < 30 µg/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: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• GDS capsule with meal
GDS capsule with meal
• Ferrous sulfate with meal
Ferrous sulfate with 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		1, 2, 4 and 8 hours on days 1 and 8	No
Primary	Fractional iron absorption		2 weeks after test meal consumption	No
Secondary	Serum isotope appearance		1, 2, 4 and 8 hours on days 1 and 8	No