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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02225886 |
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Date of registration:
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23/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients
FeVitC |
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Scientific title:
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Effects of Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients With Iron Overload |
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Date of first enrolment:
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February 1, 2020 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02225886 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Romania
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Contacts
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Name:
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Gabriel Mircescu, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Anemia Working Group Romania |
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Name:
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Aurelian Simionescu, MD, PhD |
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Address:
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Telephone:
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+40732161768 |
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Email:
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relusimionescu@yahoo.com |
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Affiliation:
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Name:
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Tudor Simionescu, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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"Carol Davila" Teaching Hospital of Nephrology |
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Name:
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Liliana Garneata, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Anemia Workiing Group Romania |
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Name:
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Liliana Garneata, MD, PhD |
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Address:
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Telephone:
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+40722619358 |
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Email:
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liliana.garneata@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anaemia Response to the Treatment
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Peripheral Iron Indices
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Oxalemia
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Intervention(s)
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Drug: Ascorbic Acid
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Primary Outcome(s)
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Variation of erythropoetin resistance index (ERI)
[Time Frame: 12 months]
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Secondary Outcome(s)
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Variation of serum hepcidin
[Time Frame: 12 months]
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Local and general tolerance to vitamin C
[Time Frame: 12 months]
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The number of withdrawals and dropouts
[Time Frame: 12 months]
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Oxalemia
[Time Frame: 12 months]
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Percentage of patients with hemoglobin within target
[Time Frame: 12 months]
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Percentage of patients with Hb in the target range
[Time Frame: 12 months]
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Percentage of patients with target iron status
[Time Frame: 12 months]
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Adverse events
[Time Frame: 12 months]
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Changes in ESA dose
[Time Frame: 12 months]
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Variation in ESA dose
[Time Frame: 12 months]
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Variation of iron dose
[Time Frame: 12 months]
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Secondary ID(s)
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AWGRO 06/2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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