NCT00952302

Brief Summary

The study hypothesis is that body iron levels are important in determining the increase in lung blood pressure that occurs in response to low oxygen levels. The purpose of this study is to determine whether this is true at high altitude, where oxygen levels are low.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

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

October 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

1 month

First QC Date

August 4, 2009

Last Update Submit

August 4, 2009

Conditions

Pulmonary HypertensionMountain Sickness

Keywords

HypoxiaIronHypoxia-Inducible Factor 1Chronic mountain sickness

Outcome Measures

Primary Outcomes (1)

  • Change in pulmonary artery systolic pressure

    One week (SLR arm) and one month (CMS arm)

Study Arms (4)

CMS - placebo first

PLACEBO COMPARATOR

Patients with chronic mountain sickness (CMS) who are venesected and studied for several weeks. In the final crossover period of the study, patients receive a placebo (saline) infusion first followed by iron infusion.

Procedure: VenesectionDrug: Iron sucroseDrug: Normal saline

CMS - iron

EXPERIMENTAL

Patients with chronic mountain sickness (CMS) who are venesected and studied for several weeks. In the final crossover period of the study, patients receive an iron infusion first followed by placebo (saline) infusion.

Procedure: VenesectionDrug: Iron sucroseDrug: Normal saline

SLR - placebo

PLACEBO COMPARATOR

Sea level residents (SLR) taken to high altitude for one week, and receiving placebo (saline) infusion on Day 3 at high altitude.

Drug: Normal saline

SLR - iron

EXPERIMENTAL

Sea level residents (SLR) taken to high altitude for one week, and receiving iron infusion on Day 3 at high altitude.

Drug: Iron sucrose

Interventions

Iron sucroseDRUG

Single intravenous infusion of iron 200 mg

Also known as: Venofer
SLR - iron
Normal salineDRUG

Single intravenous infusion of normal 0.9% saline 100 mls (as placebo)

SLR - placebo
VenesectionPROCEDURE

Isolvolaemic venesection of total 2 litres of blood - 500 mls each day for 4 days, replaced with normal saline.

CMS - ironCMS - placebo first

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • sea level natives of lowland ancestry
  • generally in good health
  • detectable tricuspid regurgitation on echocardiography

You may not qualify if:

  • any significant medical problem
  • known susceptibility to high altitude pulmonary or cerebral oedema
  • taking medications or iron supplements
  • CMS ARM
  • diagnosis of chronic mountain sickness
  • no recent venesection therapy (within 1 year)
  • detectable tricuspid regurgitation on echocardiography
  • any other significant medical problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Peruana Cayetano Heredia

Lima, 31, Peru

Location

Related Publications (1)

  • Smith TG, Talbot NP, Privat C, Rivera-Ch M, Nickol AH, Ratcliffe PJ, Dorrington KL, Leon-Velarde F, Robbins PA. Effects of iron supplementation and depletion on hypoxic pulmonary hypertension: two randomized controlled trials. JAMA. 2009 Oct 7;302(13):1444-50. doi: 10.1001/jama.2009.1404.

    PMID: 19809026DERIVED

MeSH Terms

Conditions

Hypertension, PulmonaryAltitude SicknessHypoxia

Interventions

Ferric Oxide, SaccharatedSaline SolutionPhlebotomy

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsBlood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Peter A Robbins, BMBCh DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

October 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

PE(1)