Trial record 18 of 101 for:    Open Studies | "Ascorbic Acid"

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

This study is currently recruiting participants.
Verified August 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01926132
First received: August 16, 2013
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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

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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • fatigue scale [ Time Frame: 2 weeks after 10g ascorbic aicd intravenous injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mitochondrial DNA copy number on blood and salivary samples [ Time Frame: 2 weeks after 10g ascorbic aicd intravenous injection ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01926132

Contacts
Contact: Jae Yong Shim, MD 82-2-2019-3480 hope@yuhs.ac

Locations
Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Jae Yong Shim, MD    82-2-2019-3480    hope@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01926132     History of Changes
Other Study ID Numbers: 3-2012-0154
Study First Received: August 16, 2013
Last Updated: August 19, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
ascorbic acid
fatigue
mitochondrial DNA
patient for more than 6 months

Additional relevant MeSH terms:
Ascorbic Acid
Fatigue
Signs and Symptoms
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014