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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926132

Enrollment

Registered

2013-08-20

Start date

2013-08-31

Completion date

2013-10-31

Last updated

2013-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue

Keywords

ascorbic acid, fatigue, mitochondrial DNA, patient for more than 6 months

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.

Interventions

DRUGascorbic acid 10g/20ml

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

DRUGNormal Saline 150ml

Normal Saline 150ml intravenous injection for 40mins

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
fatigue scale	2 weeks after 10g ascorbic aicd intravenous injection

Secondary

Measure	Time frame
mitochondrial DNA copy number on blood and salivary samples	2 weeks after 10g ascorbic aicd intravenous injection

Countries

South Korea

Contacts

Primary ContactJae Yong Shim, MD

hope@yuhs.ac82-2-2019-3480

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026