High-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study

Study Overview
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Brief Summary
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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
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Chronic Fatigue

Intervention / Treatment
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* Drug: ascorbic acid 10g/20ml
* Drug: Normal Saline 150ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ascorbic acid 10g/20ml<br>Normal Saline 130ml+ ascorbic acid 10g/20ml , covered bottle for the blind allocation | Drug: ascorbic acid 10g/20ml<br>* ascorbic acid 10g/20cc intravenous injection for 40mins<br>|
| Active Comparator: Normal Saline 150ml<br>Normal Saline 150ml, covered bottle | Drug: Normal Saline 150ml<br>* Normal Saline 150ml intravenous injection for 40mins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue scale |  | 2 weeks after 10g ascorbic aicd intravenous injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mitochondrial DNA copy number on blood and salivary samples |  | 2 weeks after 10g ascorbic aicd intravenous injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ascorbic acid, fatigue, mitochondrial DNA, patient for more than 6 months