Study of the Effects of Iron Levels on the Lungs at High Altitude

NCT00952302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2009-08-06

No results posted yet for this study

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.

Conditions

  • Pulmonary Hypertension
  • Mountain Sickness

Interventions

DRUG

Iron sucrose

Single intravenous infusion of iron 200 mg

DRUG

Normal saline

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

PROCEDURE

Venesection

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

DRUG

Iron sucrose

Two intravenous infusions, each of 200 mg of iron, separated by one day.

DRUG

Normal saline

Two intravenous infusions of normal 0.9% saline 100 mls (as placebo), separated by one day.

Sponsors & Collaborators

  • Universidad Peruana Cayetano Heredia

    collaborator OTHER
  • University of Oxford

    lead OTHER

Principal Investigators

  • Peter A Robbins, BMBCh DPhil · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00952302 on ClinicalTrials.gov