NCT01985386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 30, 2014

Status Verified

July 1, 2014

Enrollment Period

1 month

First QC Date

October 31, 2013

Last Update Submit

July 29, 2014

Conditions

Iron Deficiency

Keywords

Iron absorptionSlow release ironGastric delivery systemIron deficiency

Outcome Measures

Primary Outcomes (1)

  • Fractional iron absorption

    2 weeks after test meal consumption

Secondary Outcomes (1)

  • Serum isotope appearance

    1, 2, 4 and 8 hours on days 1 and 8

Other Outcomes (1)

  • Serum non transferrin bound iron

    1, 2, 4 and 8 hours on days 1 and 8

Study Arms (2)

GDS (gastric delivery system), meal

EXPERIMENTAL

GDS capsule with meal

Dietary Supplement: GDS capsule with meal

Ferrous sulfate, meal

ACTIVE COMPARATOR

Ferrous sulfate with meal

Dietary Supplement: Ferrous sulfate with meal

Interventions

GDS capsule with mealDIETARY_SUPPLEMENT

GDS capsule with meal

GDS (gastric delivery system), meal
Ferrous sulfate with mealDIETARY_SUPPLEMENT

Ferrous sulfate with meal

Ferrous sulfate, meal

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female,
  • age 18-50 years,
  • max. body weight 65 kg,
  • serum ferritin \< 30 µg/l

You may not qualify if:

  • pregnancy,
  • lactation,
  • regular intake of medication,
  • blood donation or significant blood losses over the past 4 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Laboratory, ETH Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous sulfateMeals

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Isabelle Aeberli, PhD

    ETH Zurich (Switzerland)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 15, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

July 30, 2014

Record last verified: 2014-07

Locations

CH(1)