Investigating The Effect Of Vitamin B6 On Reducing Xerostomia And Blood Pressure Drop In Hemodialysis Patients Of Yasuj City: A Study Andomized Clinical Trial

The Determination Of The Effect Of Vitamin B6 On The Reduction Of Xerostomia And Blood Pressure Drop In Hemodialysis Patients In Yasuj.

A Clinical Trial With A Control Group, With Parallel Groups, Double-Blind, Randomized, Phase 3 On 50 Patients. Online Sites Will Be Used For Randomization.

Patients With Chronic Kidney Failure Who Are Undergoing Hemodialysis And Referred To Shahid Jalil Hospital In Yasuj For This Treatment Will Be Included In The Study. The Study Will Be A Double-Blind Study, In Which Both The Patient And The Evaluator Will Be Blinded. The Duration Of The Intervention Will Be Three Months.

Inclusion: Medical Diagnosis Of Chronic Renal Failure, Degree Of Dry Mouth Based On Fox Index Questionnaire Exclusion: Chronic Physical Disorders Such As Debilitating Heart, Respiratory, And Liver Diseases

In This Study, The Intervention Group Will Receive 40 Mg Of Vitamin B6 Supplementation Daily For Three Months. During This Time, The Control Group Will Continue Its Routine And Standard Treatment.

Xerostomia , Blood Pressure

The Method Of Block Randomization Will Be Used To Assign Individuals To The Study Groups. The Advantage Of Blocked Randomization Is That It Ensures The Balance Of The Number Of Patients In Each Group. The Groups Will Be Defined As Codes A And B. Group A Will Be Considered The Intervention Group And Group B The Control Group. Before Assigning Individuals To One Of The Groups, A List Of Letters (A, B), Or In Other Words, Blocks Will Be Created. A Reputable Website, Https://Www.Sealedenvelope.Com, Will generate this Random Assignment List. Each Eligible And Attending Individual Will Be Assigned To One Of The Groups According To The Created List. To Prevent Predictable Assignment Of Individuals To The Different Groups, Blocks Of Varying Sizes (2, 4, 6, And 8) Will Be Created. Pair Blocks Will Appear As AB - Four-Member Blocks As ABAB - Six-Member Blocks As AABABB - And Eight-Member Blocks As ABBABABA.

In This Study, A Double-Blind Design Will Be Employed; In Such A Way That Both Patients And Outcome Assessors Will Be Blinded To The Type Of Intervention (Intake Of Vitamin B6 Or Its Absence). Considering That Patients Undergoing Hemodialysis Typically Receive Multiple Medications, And To Avoid Further Complexity In The Treatment Process, The Use Of A Placebo Has Not Been Anticipated In This Study. To Uphold Ethical Principles And Ensure Adherence To Informed Consent Guidelines, Patients Will Be Provided With A Brief Explanation That They Will Receive A Supplement As Part Of The Nutritional Assessment Process In A Clinical Study Involving Dialysis Patients. The Distribution And Administration Of The Supplement Will Be Conducted By An Individual Outside The Assessment Team.

Three Month After The Completion Of The Intervention, The Data Of The Main Variables Of The Study Will Be Shared.

The Commencement Of The Access Period Is 3 Months After The Publication Of The Results.

After The Publication Of The Article, All Individuals Will Have Access To Its Content.

Individuals Associated With The Medical And Therapeutic Field May Utilize The Data From This Study To Conduct New Research

Submitting A Request To The Corresponding Author Of The Article

The Applicant Must Submit Their Formal Request Via The Organization's Email To The Email Of The Responsible Author. The Responsible Author Will Provide The Information To The Applicant Within A Maximum Of Two Weeks Upon Confirmation Of The Information.