HealthyNCT00946933
Effects of Chronic Acid-Base Changes on Ventilatory and Perceptual Responses
A study testing NH4Cl (ammonium chloride) in people with Healthy, run by Queen's University at 1 site in Canada.
Trial summary
Approximately 30% of people aged 65 years and older experience breathlessness (perceived respiratory difficulty) during daily activity. The main causes of increased breathlessness in the healthy elderly are poorly understood and are the main focus of the proposed study. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NH4Cl (ammonium chloride)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy, regularly active adults
- non-smoking
- BMI 18-30 kg/m2
Who cannot join
- history of lung and/or heart disease (including cardiac arrhythmias) or other comorbidity which could interfere with proper conduct of the intervention or tests
- hypotension or hypertension
- hypercholesterolemia
- sleep disordered breathing
- inability to perform cycle exercise or comply with other testing procedures
Trial locations and contacts
1 site in 1 country.
Canada1 site
Respiratory Investigation Unit at Kingston General Hospital
Kingston, Ontario, K7L 2V7
About this study
Official title: Effects of Chronic Acid-Base Changes on the Ventilatory and Perceptual Response to Hypercapnia, Hypoxia and Exercise in Healthy Older Adults
Approximately 30% of people aged 65 years and older experience breathlessness (perceived respiratory difficulty) during daily activity. The main causes of increased breathlessness in the healthy elderly are poorly understood and are the main focus of the proposed study. Some possible contributing factors include abnormalities in the control and/or mechanics of breathing. To evaluate these possible contributory factors, the investigators will compare ventilatory and perceptual responses to: 1) exercise, 2) increased levels of inspired carbon dioxide, and 3) reduced levels of inspired oxygen under strictly-controlled experimental conditions where the investigators increase or decrease breathing requirements by altering dietary salt intake in healthy 40-80 year old men and women.
Exercise and rebreathing tests will be performed at baseline and at the end of each 3 day treatment period. Breathlessness intensity will be measured and compared at a standardized work rate, ventilation or end-tidal PCO2 during these tests.
- Conditions
- Healthy
- Being tested
- NH4Cl (ammonium chloride), placebo
- Keywords
- acid-base balance, ventilatory control, dyspnea, exercise, modified rebreathing procedure, Normal, older
- Medical subject headings
- Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NH4Cl (ammonium chloride)Dietary supplement
0.2 g/kg/day of NH4Cl (ammonium chloride)
placeboDietary supplement
0.025 g/kg/day of NaCl (sodium chloride)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.025 g/kg/day of NaCl (sodium chloride) Receives: Dietary Supplement: placebo |
| High salt diet | Active comparator | 0.2 g/kg/day of NH4Cl (ammonium chloride) Receives: Dietary Supplement: NH4Cl (ammonium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness intensity (10-point Borg scale)
Measured: Measured at the end of each 3 day treatment period
Secondary outcomes (1)
Exercise capacity (peak VO2)
Measured: Measured at the end of each 3 day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Denis O'Donnell, Queen's University
- Investigators
- Denis E O'Donnell, MD, FRCPC, Principal investigator, Queen's University and Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946933
- Sponsor's protocol ID
- DSS-16198
- Status last verified
- Dec 2012
- First submitted
- 23 Jul 2009
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chronic Acid-Base Changes on the Ventilatory and Perceptual Response to Hypercapnia, Hypoxia and Exercise in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT00946933
- Acronym / sponsor ID
- DSS-16198
- Conditions
- Healthy
- Keywords
- acid-base balance, ventilatory control, dyspnea, exercise, modified rebreathing procedure, Normal, older
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 30% of people aged 65 years and older experience breathlessness (perceived respiratory difficulty) during daily activity. The main causes of increased breathlessness in the healthy elderly are poorly understood and are the main focus of the proposed study. Some possible contributing factors include abnormalities in the control and/or mechanics of breathing. To evaluate these possible contributory factors, the investigators will compare ventilatory and perceptual responses to: 1) exercise, 2) increased levels of inspired carbon dioxide, and 3) reduced levels of inspired oxygen under strictly-controlled experimental conditions where the investigators increase or decrease breathing requirements by altering dietary salt intake in healthy 40-80 year old men and women.
Exercise and rebreathing tests will be performed at baseline and at the end of each 3 day treatment period. Breathlessness intensity will be measured and compared at a standardized work rate, ventilation or end-tidal PCO2 during these tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: placebo0.025 g/kg/day of NaCl (sodium chloride) |
| High salt diet | Active comparator | Dietary Supplement: NH4Cl (ammonium chloride)0.2 g/kg/day of NH4Cl (ammonium chloride) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy, regularly active adults
- non-smoking
- BMI 18-30 kg/m2
Key exclusion criteria (5 listed)
- history of lung and/or heart disease (including cardiac arrhythmias) or other comorbidity which could interfere with proper conduct of the intervention or tests
- hypotension or hypertension
- hypercholesterolemia
- sleep disordered breathing
- inability to perform cycle exercise or comply with other testing procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NH4Cl (ammonium chloride)0.2 g/kg/day of NH4Cl (ammonium chloride) | Dietary supplement | High salt diet |
| placebo0.025 g/kg/day of NaCl (sodium chloride) | Dietary supplement | Placebo |
Primary outcome
Breathlessness intensity (10-point Borg scale)
Time frame: Measured at the end of each 3 day treatment period
1 secondary outcome
Exercise capacity (peak VO2)
Time frame: Measured at the end of each 3 day treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis E O'Donnell, MD, FRCPC principal investigator
Queen's University and Kingston General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NH4Cl (ammonium chloride) in people with Healthy, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness intensity (10-point Borg scale) (time frame: Measured at the end of each 3 day treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.