Effects of Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients With Iron Overload
Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients
Sponsors
Source
Anemia Working Group Romania
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
The administration of ascorbic acid seemed to increase the iron available for erythropoiesis,
thus improving the anemia response to the treatment.
The investigators therefore aimed to evaluate the effects of intravenous ascorbic acid
administration in hemodialysed patients with iron overload.
Detailed Description
Renal anemia is a complex condition in which chronic inflammation, among other factors, can
change the iron distribution by locking it in deposits, and also, iron metabolism parameters.
Thus, is hard to separate the iron functional deficit from overload.
The ascorbic acid is a hydrosoluble vitamin capable of reduction and hydrolysis. As a
reduction agent, the ascorbic acid supports the transformation of ferric iron to ferrous
iron. For instance, the ascorbic acid can increase digestive absorption and taking over the
iron without transferrin, helps iron release from ferritin and hemosiderin and delays
ferritin conversion to hemosiderin; therefore, the administration of ascorbic acid can
increase the quantity of iron available for erythropoiesis by realising it from the deposits.
Consequently, the antioxidant function of ascorbic acid can increase the red cells' lifetime,
reducing the inflammation and improving erythropoietin response Following these premises,
recent studies have examined the effect of administrating ascorbic acid to hemodialysed
patients with erythropoiesis stimulating agents (ESA) hyporesponsiveness anemia and
functional deficit or iron overload markers. The results of administering ascorbic acid
revealed an increased level of hemoglobin and transferrin saturation (TSAT) combined with the
decrease of ESA doses. The major limitations of these studies are the short amount of time
for observation (<6months) and the limited number of participants which hampered neither the
complete evaluation of the goals, nor the adverse effects of supplementary administration of
vitamin C.
Until now, the Clinical practice guidelines of Kidney Disease do not recommend currently
using of high doses of vitamin C, considering the risk of a high level of oxalemia and the
limited information about the benefits. Considering this background, we intended to evaluate
the benefits of intravenous administration of ascorbic acid in hemodialysed patients with
iron balance markers suggestive for iron overload.
Overall Status
Not yet recruiting
Start Date
2019-10-01
Completion Date
2022-12-01
Primary Completion Date
2022-03-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Variation of erythropoetin resistance index (ERI) |
12 months |
Secondary Outcome
Measure |
Time Frame |
|
Percentage of patients with Hb in the target range |
12 months |
|
Changes in ESA dose |
12 months |
|
Variation in ESA dose |
12 months |
|
Variation of iron dose |
12 months |
|
Percentage of patients with hemoglobin within target |
12 months |
|
Percentage of patients with target iron status |
12 months |
|
Variation of serum hepcidin |
12 months |
|
Oxalemia |
12 months |
|
Local and general tolerance to vitamin C |
12 months |
|
Adverse events |
12 months |
|
The number of withdrawals and dropouts |
12 months |
Enrollment
100
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
300 mg of intravenous ascorbic acid will be given 3 times a week, postdialysis, in 100 mL saline solution, except for the dialysis sessions when iv iron is administered
Arm Group Label
Ascorbic acid
Control group
Eligibility
Criteria
Inclusion Criteria:
- Age above 18 years old
- At least 6 months on hemodialysis at the time of randomization;
- Kt/V≥1.2;
- average of the last three serum ferritin levels > 500 ng/mL AND
- Average of the last three TSAT levels > 20% and increasing
- ERI in the 4th quartile of the group
Exclusion Criteria:
- Active bleeding or other cause of anemia
- Serum level of intact parathyroid hormone (iPTH)>800 pg/mL
- Actual neoplasia
- HIV, Hepatitis B or C infections
- Significant inflammation (CRP>12mg/L) or acute infection
- Venous central catheter
- Severe hepatic, cardiovascular, psychic disease or other severe comorbidities
- Moderate or severe malnutrition
- Blood transfusions in the 2 months prior to screening
- Pregnancy or breastfeeding
- Inclusion in another clinical trial in the past month
Gender
All
Minimum Age
18 Years
Maximum Age
85 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Gabriel Mircescu, Professor |
Study Chair |
Anemia Working Group Romania |
|
Liliana Garneata, MD, PhD |
Study Director |
Anemia Workiing Group Romania |
|
Tudor Simionescu, MD, PhD |
Principal Investigator |
"Carol Davila" Teaching Hospital of Nephrology |
Overall Contact
Location
Facility |
Status |
Contact |
|
"Nefrolab" Dialysis Center Slatina Romania |
Not yet recruiting |
Location Countries
Country
Romania
Verification Date
2019-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Ascorbic Acid
Arm Group
Arm Group Label
Ascorbic acid
Arm Group Type
Experimental
Description
Patients will receive a 300 mg intravenous ascorbic acid, 3 times a week, postdialysis, except for the dialysis sessions when iv iron is administered.
Arm Group Label
Control group
Arm Group Type
Placebo Comparator
Description
Patients will receive 100 mL saline solution, 3 times a week, with associated medication, except but the dialysis sessions when iv iron is administered.
Firstreceived Results Date
N/A
Overall Contact Backup
Acronym
FeVitC
Patient Data
Sharing Ipd
Yes
Ipd Description
Publication
Ipd Info Type
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Ipd Time Frame
24 months
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
August 23, 2014
Study First Submitted Qc
August 25, 2014
Study First Posted
August 26, 2014
Last Update Submitted
January 8, 2019
Last Update Submitted Qc
January 8, 2019
Last Update Posted
January 9, 2019
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.