Vitamin C DeficiencyPhase 1/2NCT03224572
The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients
A Phase 1/2 study testing high-dose vitamin C 30gm and normal saline in people with Vitamin C Deficiency, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study determines whether high dose vitamin C is effective for quality of life in terminal cancer patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Vitamin C Deficiency
- What is being tested?
- high-dose vitamin C 30gm and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2018to Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Terminal colon cancer patients without pleural effusions, who will not receive any curative radiotherapy or chemotherapy.
Who cannot join
- Renal metastasis or obstructive uropathy by radiology
- Nephrotic syndrome
- Creatinine over 1.5mg/dl
- Urolithasis
- Under other folk therapy or vitamin infusion therapy
- Those who can't exercise the right of consent
Show all 9Show fewer
- Those who can't answer the questionaires
- Glucose-6-Phosphate Dehydrogenase Deficiency
- Severe lower leg edema or general edema
Trial locations and contacts
1 site in 1 country.
About this study
This study determines whether high dose vitamin C is effective for quality of life in terminal cancer patients.
Read the detailed description
The investigator's project is a single medical center, randomized double- blinded trial. The target group is terminal cancer patients at Palliative care clinics. The experimental group will receive intravenous high-dose vitamin C 30 g in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The primary outcome is the improvement of quality of life, measured by European Organization for Research and Treatment of cancer (EORTC). The secondary outcome is the survival analysis.The participants will be followed up weekly for 2 weeks, then bi-weekly for 6 months.
- Conditions
- Vitamin C Deficiency
- Being tested
- high-dose vitamin C 30gm, normal saline
- Keywords
- vitamin C, quality of life, terminal cancer
- Medical subject headings
- Ascorbic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-dose vitamin C 30gmDrug
Also called ascorbic acid 30 gm
High-dose vitamin C 30 gm in 500 ml normal saline, once per week, and total 4-week treatment.
normal salineOther
500ml normal saline, once per week, and total 4-week treatment
| Study group | Role | What they receive |
|---|---|---|
| The study group | Experimental | The study group will receive intravenous high-dose vitamin C 30 gm in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. Receives: Drug: high-dose vitamin C 30gm; Other: normal saline |
| The control group | Placebo comparator | The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of quality of life (QOL)
QOL measured by European Organization for Research and Treatment of cancer Quality of Life Questionnaire (EORTC QLQ)-C30
Measured: 6 months
Secondary outcomes (1)
Survival analysis
death time of those who have completed the 4-week intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startJan 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin C DeficiencyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Randomized double-blinded controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Ying Chen, MD, MHSc, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224572
- Sponsor's protocol ID
- 201702008MIPB
- Status last verified
- Apr 2017
- First submitted
- 16 Jul 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients
- ClinicalTrials.gov ID
- NCT03224572
- Acronym / sponsor ID
- 201702008MIPB
- Conditions
- Vitamin C Deficiency
- Keywords
- vitamin C, quality of life, terminal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study determines whether high dose vitamin C is effective for quality of life in terminal cancer patients.
Detailed description
The investigator's project is a single medical center, randomized double- blinded trial. The target group is terminal cancer patients at Palliative care clinics. The experimental group will receive intravenous high-dose vitamin C 30 g in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The primary outcome is the improvement of quality of life, measured by European Organization for Research and Treatment of cancer (EORTC). The secondary outcome is the survival analysis.The participants will be followed up weekly for 2 weeks, then bi-weekly for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel Assignment Randomized double-blinded controlled trial
| Arm | Type | Receives |
|---|---|---|
| The study group | Experimental | Drug: high-dose vitamin C 30gm, Other: normal salineThe study group will receive intravenous high-dose vitamin C 30 gm in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. |
| The control group | Placebo comparator | Other: normal salineThe control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Terminal colon cancer patients without pleural effusions, who will not receive any curative radiotherapy or chemotherapy.
Key exclusion criteria (9 listed)
- Renal metastasis or obstructive uropathy by radiology
- Nephrotic syndrome
- Creatinine over 1.5mg/dl
- Urolithasis
- Under other folk therapy or vitamin infusion therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-dose vitamin C 30gmAlso: ascorbic acid 30 gmHigh-dose vitamin C 30 gm in 500 ml normal saline, once per week, and total 4-week treatment. | Drug | The study group |
| normal saline500ml normal saline, once per week, and total 4-week treatment | Other | The control group, The study group |
Primary outcome
The improvement of quality of life (QOL)
Time frame: 6 months
QOL measured by European Organization for Research and Treatment of cancer Quality of Life Questionnaire (EORTC QLQ)-C30
1 secondary outcome
Survival analysis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Vitamin C Deficiency
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Link Between ASCorbemia Level and Osteoporosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Ying Chen, MD, MHSc principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing high-dose vitamin C 30gm and normal saline in people with Vitamin C Deficiency, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin-Ying Chen, MD, MHSc (886-2-23123456 ext. 66828, crystalcychen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of quality of life (QOL) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.