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IRCT20240208060941N2 IRCT 2024-02-21 Pak Emirates Military Hospital Effect of Sodium Bicarbonate in improving health of Chronic Kidney Disease patients. Effect of Sodium Bicarbonate supplementation on improving nutritional status amongst patients on Maintenance Hemodialysis. 2023-08-15 anticipated 26 Complete https://irct.ir/trial/75632 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done using computer-generated sequences, prepared online. N/A End Stage Renal Disease. Intervention 1: Control group: This group will recieve no drug. Intervention 2: Intervention group: This group will recieve sodium bicarbonate. Yes - There is a plan to make this available What will be shared: The Deidentified Individual Participant Data Set, Study Protocol, Statistical Analysis Plan, and Informed Consent forms will be made available to desirous researchers upon reasonable requests, and after clearance from the institutional data registry body. The said documents will be shared in a non-editable format via email after scrutinizing the need for subject documents by the requesting authorities. When: The above-mentioned documents will be available after December 2024 for 5 years as per institutional data registry protocols. To whom: The data will be available only for non-commercial research purposes and will be provided to academic institutions only. Conditions: The data/ document can be used for literary and non-commercial purposes. Where to obtain: The Data can be obtained via email from: Dr Muhammad Iqbal Department of Medicine, Pak Emirates Military Hospital, Abid Majeed Road, Rawalpindi, Punjab, Pakistan, 46000. Email: iqbalkharal2934@gmail.com How to obtain: Data requests can be directly made to Dr Muhammad Iqbal via email provided earlier. After the request is received, it will submitted to the Institutional Data Control and Registry Committee for necessary verification and clearance of the requested documents. Any additional information required by the committee will be forwarded to the requestee via email. After satisfying the requirements of the Institutional Data Control and Registry Committee, the requested data/ documents will shared with the requesting person via suitable means. This process may take up to 6 weeks from the date of reception of the request. Comments:
public Muhammad Iqbal
Abid Majeed Road
Rawalpindi Pakistan 46000 +92 334 7131037 Iqbalkharal2934@gmail.com Pak Emirates Military Hospital scientific Muhammad Iqbal
Abid Majeed Road
Rawalpindi Pakistan 46000 +92 334 7131037 Iqbalkharal2934@gmail.com Pak Emirates Military Hospital Pakistan Patients from either gender: male or female Patients having > 18 years of age Patients on twice weekly maintenance hemodialysis for more than 6 months Patients able to comply with study instructions Patients having serum bicarbonate levels ≤23mmol/L 18 years 65 years Both Patients having active infection or sepsis Patients with systemic conditions (unstable heart disease, congestive heart failure, dementia, cerebrovascular disease, hepatic impairment and renal tubular acidosis) Pateints with poor blood pressure Patients who had limb amputation in the past Patients on bisphosphonate therapy Patients being treated calcium or sodium bicarbonate therapy Patients not consenting to participate in the study N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Treatment - Drugs Control group: This group will recieve no drug Intervention group: This group will recieve sodium bicarbonate Nutritional Status. Timepoint: Before intervention and 2, 4, 6, 12, and 18 weeks post intitation of treatment. Method of measurement: Hand Grip Strength, Triceps Skinfold Thickness, Serum Albumin. Pak Emirates Military Hospital Approved 2023-08-08 Ethical Committee Pak Emirates Military Hospital Rawalpindi Pak Emirates Military Hospital, Mall Road Rawalpindi Punjab Pakistan