Impact of Hemodialysis on Plasma Carnitine Levels in Pati... | NCT05817799

Studies
Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease

NCT05817799

Sponsor

Bahria University

Status

Completed

Last Update Posted

Aug 9, 2024Actual

Enrollment

83Actual

Phase

Phase 2Phase 3

Conditions

Hemodialysis Complication

Interventions

L-Carnitine 500Mg thrice daily
1g L-Carnitine IV three times a week

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jul 2, 2023Actual

Completion Date

Jul 10, 2023Actual

First Submitted Date

Mar 24, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2024

Last Update Posted Date

Aug 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sadia Rehman, Senior Assistant Professor, Bahria UniversityPrincipal Investigator

Lead Sponsor

Bahria UniversityOTHER

Collaborators

Name	Class
Pakistan Navy Station Shifa Hospital	OTHER
Jinnah Postgraduate Medical Centre	OTHER_GOV
University of Karachi	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

OBJECTIVES

To assess the levels of plasma carnitine in controls and hemodialysis patients.
To give supplementary L-carnitine to study subjects for a duration of 5months.
To compare the values of plasma carnitine before and after L carnitine supplementation.
To assess the role of carnitine supplementation on biochemical and clinical parameters.

Detailed Description

.ABSTRACT INTRODUCTION Dialysis therapy can cause a decrease in both free carnitine and plasma acyl carnitines after only six months of dialysis treatment. A positive correlation between AC/FC ratio and months on HD therapy has been reported. We investigate in this study the role of oral L-carnitine supplementation on anemia, blood pressure, cardiac dysfunction and muscle cramps in hemodialysis patients.

OBJECTIVES

To assess the levels of plasma carnitine in controls and hemodialysis patients.
To give supplementary L-carnitine to study subjects for a duration of 5months.
To compare the values of plasma carnitine before and after L carnitine supplementation.
To assess the role of carnitine supplementation on biochemical and clinical parameters.

STUDY DESIGN AND SETTING: It will be a case-control study, which will be conducted in the Department of Biochemistry, University of Karachi in collaboration with Nephrology ward of JPMC, Karachi in a period of one year after approval of synopsis.

METHOD: Total 120 subjects will be included in this study which will be divided into two groups. Group A will comprise of 60 subjects of Chronic renal failure who will be the control group. Group B will comprise of 60 subjects who will be on hemodialysis for more than 1 year. Blood samples will be taken after informed consent. Group B subjects will be given L-Carnitine supplementation for five months under strict monitoring. Physical, biochemical and clinical parameters of group B subjects will be compared before and after supplementation.

RESULTS: Data will be analyzed using SPSS version 21. Results will be shared after completion of research.

CONCLUSION: conclusion will be shared after completion of research.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental	L-Carnitine 500mg thrice daily 1g L-Carnitine IV three times a week	Drug: L-Carnitine 500Mg thrice daily Drug: 1g L-Carnitine IV three times a week
control	No Intervention	no intervention given

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-Carnitine 500Mg thrice daily	Drug	L-Carnitine 500mg oral thrice daily	intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
L-Carnitine levels in hemodialysis	plasma carnitine will be detected before and after giving intervention (unit μmol/L)	5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: • Individuals of either sex (male and female).

The study included people between the ages of 18 and 50 who had had dialysis for more than two years without taking additional antioxidants.

Exclusion Criteria:

• Individuals with any other chronic ailment, such as cancer or tuberculosis.
- Patients with acute renal failure who are receiving hemodialysis.
- All subjects who refused to take part in the investigation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sadia Rehman	Bahria University Health Sciences, Karachi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinnah Post Graduate Medical Center		Karachi	Sindh	021	Pakistan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11856775	Background	Hurot JM, Cucherat M, Haugh M, Fouque D. Effects of L-carnitine supplementation in maintenance hemodialysis patients: a systematic review. J Am Soc Nephrol. 2002 Mar;13(3):708-714. doi: 10.1681/ASN.V133708.
33139659	Result	Kuwasawa-Iwasaki M, Io H, Muto M, Ichikawa S, Wakabayashi K, Kanda R, Nakata J, Nohara N, Tomino Y, Suzuki Y. Effects of L-Carnitine Supplementation in Patients Receiving Hemodialysis or Peritoneal Dialysis. Nutrients. 2020 Nov 1;12(11):3371. doi: 10.3390/nu12113371.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals