NCT01926132

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

2 months

First QC Date

August 16, 2013

Last Update Submit

August 19, 2013

Conditions

Chronic Fatigue

Keywords

ascorbic acidfatiguemitochondrial DNApatient for more than 6 months

Outcome Measures

Primary Outcomes (1)

  • fatigue scale

    2 weeks after 10g ascorbic aicd intravenous injection

Secondary Outcomes (1)

  • mitochondrial DNA copy number on blood and salivary samples

    2 weeks after 10g ascorbic aicd intravenous injection

Study Arms (2)

ascorbic acid 10g/20ml

EXPERIMENTAL

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

Drug: ascorbic acid 10g/20ml

Normal Saline 150ml

ACTIVE COMPARATOR

Normal Saline 150ml, covered bottle

Drug: Normal Saline 150ml

Interventions

ascorbic acid 10g/20mlDRUG

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

ascorbic acid 10g/20ml
Normal Saline 150mlDRUG

Normal Saline 150ml intravenous injection for 40mins

Normal Saline 150ml

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, Seoul, 135-720, South Korea

RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

Ascorbic AcidSaline Solution

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Jae Yong Shim, MD

CONTACT

82-2-2019-3480hope@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2013

First Posted

August 20, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations

KR(1)