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

Chronic Fatigue Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01926132
• Other study ID #: 3-2012-0154
• Status: Recruiting
• Phase: Phase 4
• First received: August 16, 2013
• Last updated: August 19, 2013
• Start date: August 2013
• Est. completion date: October 2013

Study information

• Verified date: August 2013
• Source: Yonsei University
• Contact: Jae Yong Shim, MD
• Phone: 82-2-2019-3480
• Email: hope[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue
• Fatigue

Intervention

Drug:
• ascorbic acid 10g/20ml
ascorbic acid 10g/20cc intravenous injection for 40mins
• Normal Saline 150ml
Normal Saline 150ml intravenous injection for 40mins

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue scale		2 weeks after 10g ascorbic aicd intravenous injection	No
Secondary	mitochondrial DNA copy number on blood and salivary samples		2 weeks after 10g ascorbic aicd intravenous injection	No