Iron Absorption From GDS Capsules II

Not Applicable

Completed

• Conditions: Iron Deficiency
• Interventions: Dietary Supplement: GDS capsule with meal; Dietary Supplement: Ferrous sulfate with meal

• Registration Number: NCT01985386
• Lead Sponsor: Swiss Federal Institute of Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-31
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-15
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GDS (gastric delivery system), meal	GDS capsule with meal	GDS capsule with meal
Ferrous sulfate, meal	Ferrous sulfate with meal	Ferrous sulfate with meal

Primary Outcome Measures

Name	Time	Method
Fractional iron absorption	2 weeks after test meal consumption

Secondary Outcome Measures

Name	Time	Method
Serum isotope appearance	1, 2, 4 and 8 hours on days 1 and 8

Trial Locations

Locations (1)

Human Nutrition Laboratory, ETH Zurich; 🇨🇭 Zurich, Switzerland