Chronic FatiguePhase 4NCT01926132
High-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study
A Phase 4 study testing ascorbic acid 10g/20ml and Normal Saline 150ml in people with Chronic Fatigue, run by Yonsei University at 1 site in South Korea.
Trial summary
Reactive Oxygen Species (ROS) can cause oxidative damage, resulting in oxidation of lipids, proteins and DNA. In fatigue patients, there are some evidences of oxidative damage to DNA. Ascorbic acid was known to protect mitochondrial injury against oxidative stress by depolarizing the mitochondrial membrane. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue
- What is being tested?
- ascorbic acid 10g/20ml and Normal Saline 150ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Oct 2013
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with above 18 years old and 6 month fatigue duration
- Moderate to severe fatigue scale (Brief fatigue inventory-Korean version scale ≥ 4)
- Normal limit values in the screening test (White blood cell count, Hemoglobin, Creatinine, SGOT/SGPT, Thyroid stimulating hormone, Urinalysis)
- Normal limit values in glucose 6 phosphate dehydrogenase level
- Agree the subjects explanation
Who cannot join
- pregnancy and lactation
- acute common cold, acute gastroenteritis, uncontrolled diabetes, uncontrolled hypertension, liver disease or renal disease
- previous medical history, affectable by high-dose ascorbic acid (gout, renal calculi and glucose 6 phosphate dehydrogenase deficiency)
- hypersensitivity from ascorbic acid
- vitamin supplement intake until 2 days ago
- drug interactions with ascorbic acid ( aspirin, Fe, phenytoin, estrogen, tetracycline, coumarin, corticosteroid)
- Do not read a consent fom
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul, Seoul, 135-720
Jae Yong Shim, MD, 82-2-2019-3480, hope@yuhs.ac
About this study
Reactive Oxygen Species (ROS) can cause oxidative damage, resulting in oxidation of lipids, proteins and DNA. In fatigue patients, there are some evidences of oxidative damage to DNA. Ascorbic acid was known to protect mitochondrial injury against oxidative stress by depolarizing the mitochondrial membrane. The copy number of mitochondrial DNA(mtDNA) was suggested mitochondrial gene stability and biogenesis and reflected mitochondrial function. There is no evidence ascorbic acid would decrease the mtDNA damage in fatigue patients. The investigators hypothesized that decreasing in mtDNA copy number in salivary and blood sample may be reversed by high-dose vitamin C intravenous injection in fatigue patients. The investigators will compare the mtDNA copy number and fatigue scale between moderate-severe fatigue patients and control group that had not malignant and chronic illness by a randomized controlled trial.
- Conditions
- Chronic Fatigue
- Being tested
- ascorbic acid 10g/20ml, Normal Saline 150ml
- Keywords
- ascorbic acid, fatigue, mitochondrial DNA, patient for more than 6 months
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ascorbic acid 10g/20mlDrug
ascorbic acid 10g/20cc intravenous injection for 40mins
Normal Saline 150mlDrug
Normal Saline 150ml intravenous injection for 40mins
| Study group | Role | What they receive |
|---|---|---|
| ascorbic acid 10g/20ml | Experimental | Normal Saline 130ml+ ascorbic acid 10g/20ml , covered bottle for the blind allocation Receives: Drug: ascorbic acid 10g/20ml |
| Normal Saline 150ml | Active comparator | Normal Saline 150ml, covered bottle Receives: Drug: Normal Saline 150ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue scale
Measured: 2 weeks after 10g ascorbic aicd intravenous injection
Secondary outcomes (1)
mitochondrial DNA copy number on blood and salivary samples
Measured: 2 weeks after 10g ascorbic aicd intravenous injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic FatigueStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926132
- Sponsor's protocol ID
- 3-2012-0154
- Status last verified
- Aug 2013
- First submitted
- 16 Aug 2013
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT01926132
- Acronym / sponsor ID
- 3-2012-0154
- Conditions
- Chronic Fatigue
- Keywords
- ascorbic acid, fatigue, mitochondrial DNA, patient for more than 6 months
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 20 Aug 2013 (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.
Reactive Oxygen Species (ROS) can cause oxidative damage, resulting in oxidation of lipids, proteins and DNA. In fatigue patients, there are some evidences of oxidative damage to DNA. Ascorbic acid was known to protect mitochondrial injury against oxidative stress by depolarizing the mitochondrial membrane. The copy number of mitochondrial DNA(mtDNA) was suggested mitochondrial gene stability and biogenesis and reflected mitochondrial function. There is no evidence ascorbic acid would decrease the mtDNA damage in fatigue patients. The investigators hypothesized that decreasing in mtDNA copy number in salivary and blood sample may be reversed by high-dose vitamin C intravenous injection in fatigue patients. The investigators will compare the mtDNA copy number and fatigue scale between moderate-severe fatigue patients and control group that had not malignant and chronic illness by a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ascorbic acid 10g/20ml | Experimental | Drug: ascorbic acid 10g/20mlNormal Saline 130ml+ ascorbic acid 10g/20ml , covered bottle for the blind allocation |
| Normal Saline 150ml | Active comparator | Drug: Normal Saline 150mlNormal Saline 150ml, covered bottle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults with above 18 years old and 6 month fatigue duration
- Moderate to severe fatigue scale (Brief fatigue inventory-Korean version scale ≥ 4)
- Normal limit values in the screening test (White blood cell count, Hemoglobin, Creatinine, SGOT/SGPT, Thyroid stimulating hormone, Urinalysis)
- Normal limit values in glucose 6 phosphate dehydrogenase level
- Agree the subjects explanation
Key exclusion criteria (7 listed)
- pregnancy and lactation
- acute common cold, acute gastroenteritis, uncontrolled diabetes, uncontrolled hypertension, liver disease or renal disease
- previous medical history, affectable by high-dose ascorbic acid (gout, renal calculi and glucose 6 phosphate dehydrogenase deficiency)
- hypersensitivity from ascorbic acid
- vitamin supplement intake until 2 days ago
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 |
|---|---|---|
| ascorbic acid 10g/20mlascorbic acid 10g/20cc intravenous injection for 40mins | Drug | ascorbic acid 10g/20ml |
| Normal Saline 150mlNormal Saline 150ml intravenous injection for 40mins | Drug | Normal Saline 150ml |
Primary outcome
fatigue scale
Time frame: 2 weeks after 10g ascorbic aicd intravenous injection
1 secondary outcome
mitochondrial DNA copy number on blood and salivary samples
Time frame: 2 weeks after 10g ascorbic aicd intravenous injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ascorbic acid 10g/20ml and Normal Saline 150ml in people with Chronic Fatigue, run by Yonsei University at 1 site in South Korea.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Aug 2013. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Yong Shim, MD (82-2-2019-3480, hope@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue scale (time frame: 2 weeks after 10g ascorbic aicd intravenous injection). 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 20 Aug 2013.