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

NCT ID: NCT01926132

Last Updated: 2013-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-10-31

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.

Detailed Description

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Conditions

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Chronic Fatigue

Keywords

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ascorbic acid fatigue mitochondrial DNA patient for more than 6 months

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ascorbic acid 10g/20ml

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

Group Type EXPERIMENTAL

ascorbic acid 10g/20ml

Intervention Type DRUG

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

Normal Saline 150ml

Normal Saline 150ml, covered bottle

Group Type ACTIVE_COMPARATOR

Normal Saline 150ml

Intervention Type DRUG

Normal Saline 150ml intravenous injection for 40mins

Interventions

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ascorbic acid 10g/20ml

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

Intervention Type DRUG

Normal Saline 150ml

Normal Saline 150ml intravenous injection for 40mins

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adults with above 18 years old and 6 month fatigue duration
2. Moderate to severe fatigue scale (Brief fatigue inventory-Korean version scale ≥ 4)
3. Normal limit values in the screening test (White blood cell count, Hemoglobin, Creatinine, SGOT/SGPT, Thyroid stimulating hormone, Urinalysis)
4. Normal limit values in glucose 6 phosphate dehydrogenase level
5. Agree the subjects explanation

Exclusion Criteria

1. pregnancy and lactation
2. acute common cold, acute gastroenteritis, uncontrolled diabetes, uncontrolled hypertension, liver disease or renal disease
3. previous medical history, affectable by high-dose ascorbic acid (gout, renal calculi and glucose 6 phosphate dehydrogenase deficiency)
4. hypersensitivity from ascorbic acid
5. vitamin supplement intake until 2 days ago
6. drug interactions with ascorbic acid ( aspirin, Fe, phenytoin, estrogen, tetracycline, coumarin, corticosteroid)
7. Do not read a consent fom
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gangnam Severance Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Yong Shim, MD

Role: CONTACT

Phone: 82-2-2019-3480

Email: [email protected]

Facility Contacts

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Jae Yong Shim, MD

Role: primary

Other Identifiers

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3-2012-0154

Identifier Type: -

Identifier Source: org_study_id