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

August 19, 2013 updated by: Yonsei University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-720
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
          • Jae Yong Shim, MD
          • Phone Number: 82-2-2019-3480
          • Email: hope@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fatigue scale
Time Frame: 2 weeks after 10g ascorbic aicd intravenous injection
2 weeks after 10g ascorbic aicd intravenous injection

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

October 1, 2013

Study Completion (ANTICIPATED)

October 1, 2013

Study Registration Dates

First Submitted

August 16, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (ESTIMATE)

August 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2013

Last Update Submitted That Met QC Criteria

August 19, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2012-0154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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