Effects of Carnitine on Oxidative Stress to IVIR Administration to CKD Patients:Impact of Haptoglobin Genotype

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Brief Summary

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Anemia is a common disorder in CKD patients. It is largely attributed to decreased erythropoietin (EPO) production and iron deficiency. Therefore, besides EPO, therapy includes iron replenishment. However, the latter induces oxidative stress. Haptoglobin (Hp) protein is the main line of defense against the oxidative effects of Hemoglobin/Iron. There are 3 genotypes: 1-1, 2-1 and 2-2. Hp 2-2 protein is inferior to Hp 1-1 as antioxidant. So far, there is no evidence whether haptoglobin genotype affects iron-induced oxidative stress in CKD patients.

In this proposed study we wished to examine whether Hp genotype influences intravenous iron administration (IVIR)-induced oxidative stress in CKD patients, and its impact on the response of these patients to L-Carnitine therapy.

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Detailed Description

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This study will include at least 25 anemic CKD patients (stages 3-4) that will be given a weekly IVIR (Sodium ferric gluconate, \[125 mg/100 ml\] for 8 weeks, and during weeks 5-8 also received Carnitine (20mg/kg, IV) prior to IVIR. Weekly blood samples will drawn before and after each IVIR for Hp genotype, C-reactive protein (CRP), advanced oxidative protein products (AOPP), neutrophil gelatinase-associated lipocalin (NGAL), besides complete blood count and biochemical analyses.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IVIR

Patients given IV iron (Sodium ferric gluconate, \[125 mg/100 ml\] from week 1 to week 4

Group Type NO_INTERVENTION

No interventions assigned to this group

IVIR Carnitine

Patients given Carnitine (20mg/kg, IV) perior to IV iron (Sodium ferric gluconate, \[125 mg/100 ml\] from week 4 to week 8.

Group Type EXPERIMENTAL

L-Canitine

Intervention Type DRUG

Carnitine is a quaternary ammonium compound biosynthesized from the amino acids lysine and methionine, it is essential for the transport of fatty acids from the intermembraneous space in the mitochondria, into the mitochondrial matrix during the breakdown of lipids (fats) for the generation of metabolic energy

Interventions

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L-Canitine

Carnitine is a quaternary ammonium compound biosynthesized from the amino acids lysine and methionine, it is essential for the transport of fatty acids from the intermembraneous space in the mitochondria, into the mitochondrial matrix during the breakdown of lipids (fats) for the generation of metabolic energy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients that have been diagnosed as suffering from chronic kidney diseases at stages 3-4 and confirmed by MDRD.
2. CKD patients with Hb of less than 10 g%.
3. At age ≥18 y.

Exclusion Criteria

1. Pregnant women.
2. Patient with CKD stage 5 on Dialysis.
3. Patients with severe liver diseases.
4. Patients with severe CHF.
5. Inter-current illness such as fever.
6. Allergic rhinitis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No