NCT01874496

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

Study Start

First participant enrolled

May 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 13, 2013

Status Verified

September 1, 2013

Enrollment Period

1 month

First QC Date

May 13, 2013

Last Update Submit

September 12, 2013

Conditions

Iron Deficiency

Outcome Measures

Primary Outcomes (1)

  • fractional iron absorption

    2, 4, 6, and 8 weeks

Secondary Outcomes (1)

  • serum isotope appearance

    day 1, 15, 29 and 33

Other Outcomes (1)

  • Serum non transferrin bound iron

    day 1, 15, 29 and 33

Study Arms (4)

GDS, meal

EXPERIMENTAL

GDS, meal

Dietary Supplement: GDS, meal

GDS, no meal

EXPERIMENTAL

GDS, no meal

Dietary Supplement: GDS, no meal

control, no meal

ACTIVE COMPARATOR

control, no meal

Dietary Supplement: control, no meal

control, meal

ACTIVE COMPARATOR

control, meal

Dietary Supplement: control, meal

Interventions

GDS, no mealDIETARY_SUPPLEMENT

GDS, no meal

GDS, no meal
GDS, mealDIETARY_SUPPLEMENT

GDS, meal

GDS, meal
control, no mealDIETARY_SUPPLEMENT

control, no meal

control, no meal
control, mealDIETARY_SUPPLEMENT

control, meal

control, 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 \< 35µg/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, Canton of Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Meals

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

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

Study Record Dates

First Submitted

May 13, 2013

First Posted

June 11, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

September 13, 2013

Record last verified: 2013-09

Locations

CH(1)