Back to resultsHigh-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study
Primary Purpose
Chronic Fatigue
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ascorbic acid 10g/20ml
Normal Saline 150ml
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue focused on measuring ascorbic acid, fatigue, mitochondrial DNA, patient for more than 6 months
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Gangnam Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ascorbic acid 10g/20ml
Normal Saline 150ml
Arm Description
Normal Saline 130ml+ ascorbic acid 10g/20ml , covered bottle for the blind allocation
Normal Saline 150ml, covered bottle
Outcomes
Primary Outcome Measures
fatigue scale
Secondary Outcome Measures
mitochondrial DNA copy number on blood and salivary samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01926132
Brief Title
High-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue
Keywords
ascorbic acid, fatigue, mitochondrial DNA, patient for more than 6 months
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ascorbic acid 10g/20ml
Arm Type
Experimental
Arm Description
Normal Saline 130ml+ ascorbic acid 10g/20ml , covered bottle for the blind allocation
Arm Title
Normal Saline 150ml
Arm Type
Active Comparator
Arm Description
Normal Saline 150ml, covered bottle
Intervention Type
Drug
Intervention Name(s)
ascorbic acid 10g/20ml
Intervention Description
ascorbic acid 10g/20cc intravenous injection for 40mins
Intervention Type
Drug
Intervention Name(s)
Normal Saline 150ml
Intervention Description
Normal Saline 150ml intravenous injection for 40mins
Primary Outcome Measure Information:
Title
fatigue scale
Time Frame
2 weeks after 10g ascorbic aicd intravenous injection
Secondary Outcome Measure Information:
Title
mitochondrial DNA copy number on blood and salivary samples
Time Frame
2 weeks after 10g ascorbic aicd intravenous injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Yong Shim, MD
Phone
82-2-2019-3480
Email
hope@yuhs.ac
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Yong Shim, MD
Phone
82-2-2019-3480
Email
hope@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
High-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study
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