NCT02097888

Brief Summary

This will be a prospective observational study. The investigators will compare Erythropoietin (Epo) levels, erythropoiesis, and regulators of erythropoiesis, bone imaging and bone metabolism in healthy volunteers living at different altitudes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 27, 2014

Status Verified

March 1, 2014

Enrollment Period

3 years

First QC Date

March 19, 2014

Last Update Submit

March 24, 2014

Conditions

Healthy Men and Non- Pregnant Women

Outcome Measures

Primary Outcomes (1)

  • Difference of EPO level between control groups

    up to 4 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents living \< 400m over sea level and \>1500m over sea level

You may qualify if:

  • healthy men and non-pregnant women, ages ≥18-40 years and ≥ 60 years living in the predefined area

You may not qualify if:

  • Known bone pathology including osteoporosis, known haematological disease, known renal disease, heart insufficiency, pulmonal disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Baselland / Bruderholz

Bruderholz, 4101, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples Without DNA - samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma)

Study Officials

  • Sandrine Meyer-Monard, PD Dr. med.

    Kantonsspital Baselland / Bruderholz, Department of Medicine, Studienabteilung, CH-4101 Bruderholz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine Meyer-Monard, PD Dr. med.

CONTACT

041 61 436 22 03sandrine.meyer@ksbl.ch

Helga Schneider

CONTACT

0041 61 436 31 44helga.schneider@ksbl.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 27, 2014

Study Start

December 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 27, 2014

Record last verified: 2014-03

Locations

CH(1)