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

Sponsor

Yonsei University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01926132

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

29.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue	Drug: ascorbic acid 10g/20ml Drug: Normal Saline 150ml	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Oct 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: ascorbic acid 10g/20ml

Normal Saline 130ml+ ascorbic acid 10g/20ml , covered bottle for the blind allocation

Drug: ascorbic acid 10g/20ml

ascorbic acid 10g/20cc intravenous injection for 40mins

Active Comparator: Normal Saline 150ml

Normal Saline 150ml, covered bottle

Drug: Normal Saline 150ml

Normal Saline 150ml intravenous injection for 40mins

Outcome Measures

Primary Outcome Measures

fatigue scale [2 weeks after 10g ascorbic aicd intravenous injection]

Secondary Outcome Measures

mitochondrial DNA copy number on blood and salivary samples [2 weeks after 10g ascorbic aicd intravenous injection]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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