Condition category
Respiratory
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
06/05/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E.P.A. Rutten

ORCID ID

Contact details

Research
Development and Education
Centre for Integrated Rehabilitation of Organ Failure (CIRO)
Horn
6080 NM
Netherlands
ericarutten@proteion.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of nutritional supplementation as adjunct to exercise training on resting and exercise-induced oxidative stress, muscle function and exercise capacity in severe Chronic Obstructive Pulmonary Disease patients

Acronym

ROXCEN

Study hypothesis

Daily ingestion of a nutritional supplement enriched with antioxidants during eight weeks pulmonary rehabilitation results in a decreased oxidative stress in rest and after exercise in Chronic Obstructive Pulmonary Disease (COPD) patients compared to an iso-caloric placebo.

Ethics approval

Ethics approval received from the Ethical Commission of the METC of Maastricht on the 19th September 2007 (ref: NL17788.068.07/MEC 07-3-066).

Study design

Double-blind placebo controlled parallel intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Intervention

Nutritional supplement enriched with antioxidants versus iso-caloric placebo.

Intervention type

Supplement

Phase

Not Specified

Drug names

Nutritional supplement

Primary outcome measures

To assess the effect of daily ingestion of a nutritional supplement enriched with antioxidants during eight weeks pulmonary rehabilitation on resting and exercise-induced oxidative stress in COPD patients compared to an iso-caloric placebo. Oxidative stress will be measured by specific biomarkers in exhaled air, breath condensate, urine and venous blood, measured at the start of the rehabilitation and after eight weeks.

Secondary outcome measures

To examine the effects of daily ingestion of a nutritional supplement enriched with antioxidants during pulmonary rehabilitation on respiratory and skeletal muscle strength and exercise capacity in COPD patients, measured at the start of the rehabilitation and after eight weeks.

Overall trial start date

01/10/2007

Overall trial end date

01/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of COPD according to the American Thoracic Society (ATS) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (Forced Expiratory Volume in one second [FEV1] less than 60% predicted and FEV1/Forced Vital Capacity [FVC] less than 70% and less than 10% predicted improvement in FEV1 after b2-agonist inhalation
2. Both male and female, age-range from 40 to 75 years
3. No respiratory tract infection or exacerbation of the disease for at least four weeks before the study
4. Capable to provide informed consent
5. Presence of other chronic diseases is allowed in case the clinical status is stable for at least four weeks before the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Inability to perform the incremental cycle ergometer test
2. Chronic use of antioxidants or vitamin supplements
3. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
4. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
5. Specific allergy or intolerance

Recruitment start date

01/10/2007

Recruitment end date

01/07/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Research, Development and Education
Horn
6080 NM
Netherlands

Sponsor information

Organisation

Numico Research B.V. (The Netherlands)

Sponsor details

P.O.Box 7005
Wageningen
6700 CA
Netherlands

Sponsor type

Industry

Website

http://www.numico.com

Funders

Funder type

Industry

Funder name

Numico Research B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes