Correlation Of Serum Intact Parathyroid Hormone and Serum Alkaline Phosphatase Amongst the Patients of Chronic Kidney Disease in A Rural Tertiary Care Hospital in Central India
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The primary outcome of this study is to determine the correlation between serum intact parathyroid hormone (iPTH) and serum alkaline phosphatase (ALP) levels among patients with Chronic Kidney Disease (CKD) in a rural tertiary care hospital in Central India
Overview
Brief Summary
a study conducted in a rural tertiary care hospital in Central India aiming to investigate the correlation between serum intact parathyroid hormone (iPTH) and serum alkaline phosphatase (ALP) levels among patients with Chronic Kidney Disease (CKD). The rationale behind the study is to assess cost-effective investigations for diagnosing CKD mineral and bone disorder (MBD) and potentially improving patient outcomes. The study design is a cross-sectional study with a duration of 24 months, conducted at Acharya Vinoba Bhave Rural Hospital. The sample size is determined to be 120 patients meeting specific inclusion criteria. Data collection involves obtaining baseline demographic and clinical data, including age, gender, BMI, and blood pressure, and analyzing serum samples for various biochemical markers. Ethical considerations, including patient confidentiality and informed consent, are emphasized. The primary outcome is the correlation between iPTH and ALP levels, while secondary outcomes include assessing MBD prevalence, disease burden across CKD stages, and exploring factors associated with elevated iPTH and ALP levels. The abstract highlights the study’s potential contributions to CKD management in the rural Indian population.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 1.00 Day(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •This is a single-center observational prospective study conducted at the AVBRH hospital under the Department of Nephrology.
- •All patients on regular follow-up and on maintenance haemodialysis treatment from Acharya Vinoba Bhave Rural Hospital were eligible for participation, subject to the inclusion and exclusion criteria.
Exclusion Criteria
- •Age more than 18 years diagnosed to have Chronic kidney disease Stage IV, V and patient on Dialysis.
Outcomes
Primary Outcomes
The primary outcome of this study is to determine the correlation between serum intact parathyroid hormone (iPTH) and serum alkaline phosphatase (ALP) levels among patients with Chronic Kidney Disease (CKD) in a rural tertiary care hospital in Central India
Time Frame: All parameters will be assessed at the baseline at the time of enrollment.
Secondary Outcomes
- In addition to the primary outcome of correlating serum intact parathyroid hormone (iPTH) and serum alkaline phosphatase (ALP) levels in Chronic Kidney Disease (CKD) patients, this study aims to determine the prevalence of mineral and bone disorder (MBD) in CKD patients, analyze disease burden across CKD stages, explore factors influencing iPTH and ALP levels, evaluate their relationship with other biochemical markers and clinical parameters, identify predictors of adverse outcomes, assess intervention impacts on iPTH and ALP levels, and compare iPTH and ALP levels between dialysis and non-dialysis CKD patients.
Investigators
Soumya Malde
Datta Meghe Institute of Higher Education and Research