Iron Absorption From GDS Capsules II

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01985386

Enrollment

Registered

2013-11-15

Start date

2013-11-30

Completion date

2014-06-30

Last updated

2014-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

Keywords

Iron absorption, Slow release iron, Gastric delivery system, Iron deficiency

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.

Interventions

DIETARY_SUPPLEMENTGDS capsule with meal

GDS capsule with meal

DIETARY_SUPPLEMENTFerrous sulfate with meal

Ferrous sulfate with meal

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Fractional iron absorption	2 weeks after test meal consumption

Secondary

Measure	Time frame
Serum isotope appearance	1, 2, 4 and 8 hours on days 1 and 8

Other

Measure	Time frame
Serum non transferrin bound iron	1, 2, 4 and 8 hours on days 1 and 8

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026