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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 March 2024 |
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Main ID: |
NCT02448667 |
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Date of registration:
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15/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Energy Supplements to Improve Exercise Tolerance in Metabolic Myopathies
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Scientific title:
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Energy Supplements to Improve Exercise Tolerance in Metabolic Myopathies |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02448667 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Astrid E Buch, BSc Medicine |
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Address:
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Telephone:
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Email:
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Affiliation:
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Copenhagen Neuromuscular Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Genetically and/or biochemically verified GSDIIIa.
- 18 years or older.
Exclusion Criteria:
- Clinically significant cardiac or pulmonary disease.
- Pregnancy or lactation.
- Severe mental disorders or participants that are in other ways unable to understand
the purpose of the trials.
- Subjects where the investigator assess that it is not possible or very difficult to
place an intravenous catheters.
- Other conditions of the joints or skeletal muscle such as arthritis or sprains. If the
condition is expected to resolve before the study inclusion period is stopped, the
subject may be included at a later time.
- Moderate to severe muscle weakness, where the participants are not expected to
complete 10 minutes of cycle-ergometry exercise at 70 % of VO2peak.
- Verified diabetes.
- Participation in other clinical trials that may interfere with the results.
- Medications that may interfere with the results or increase the risk of bleeding.
- Blood-clotting or bleeding disorders.
- Blood donation one month or less prior to inclusion.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Glycogen Storage Disease Type III
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Intervention(s)
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Dietary Supplement: Faxe Kondi Free
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Dietary Supplement: FAXE Kondi
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Primary Outcome(s)
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maximal work capacity
[Time Frame: After up to 1 hour of bicycling on the 2nd and 4th day.]
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Secondary Outcome(s)
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Peak oxygen consumption
[Time Frame: After up to 1 hour of cycling on the 2nd and 4th day.]
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Borg score
[Time Frame: Measured periodically during the cycle test (max. 1 hour) on the 2nd and 4th day]
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Heart rate
[Time Frame: Continously during the cycle test (max. 1 hour) on the 2nd and 4th day]
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p-lactate
[Time Frame: measured at rest and max on day 1, and before first dose of soft drink, before exercise and every 10 minutes during exercise at day 2 and 4.]
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Peak respiratory exchange ratio
[Time Frame: After up to 1 hour of cycling on the 2nd and 4th day.]
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Peak workload
[Time Frame: After up to 1 hour of cycling on the 2nd and 4th day.]
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Secondary ID(s)
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H-4-2014-014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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