| CTRI Number |
CTRI/2024/06/069287 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation Between Serum Parathyroid Hormone and Alkaline Phosphatase in Chronic Kidney Disease Patients: A Study from Central India |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya Malde |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
8983366987 |
| Fax |
|
| Email |
Sunnymalde94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya Malde |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research
Datta Meghe Institute of Higher Education and Research
MAHARASHTRA
442001
India |
| Phone |
8983366987 |
| Fax |
|
| Email |
Sunnymalde94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manish Balwani |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
8983366987 |
| Fax |
|
| Email |
balwani.manish@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Medical Sciences Sawangi (Meghe) Wardha
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sunny Malde |
Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe) Wardha |
Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA |
8983366987
Sunnymalde94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences Sawangi (Meghe) Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
Age more than 18 years diagnosed to have Chronic kidney disease Stage IV, V and patient on Dialysis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
All parameters will be assessed at the baseline at the time of enrollment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
1 Month |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |