| CTRI Number |
CTRI/2025/11/097592 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
My study is about comparing the changes in blood pressure in patients having BP 140/90 to 160/100 mmHg with Vitamin D levels of 20 to 29 ng/mL taking standard of treatment which is tablet Telmisartan 40mg alone in one group and tablet Telmisartan 40mg with Vitamin D supplementation in another group |
|
Scientific Title of Study
|
A study to compare the efficacy of Telmisartan alone versus Telmisartan and Vitamin D supplementation on blood pressure in patients with stage I essential hypertension along with Vitamin D insufficiency Randomized controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Medhaveeni |
| Designation |
Junior resident |
| Affiliation |
Banglore medical college and research institute |
| Address |
Department of Pharmacology Banglore medical college and research institute
Bangalore
KARNATAKA
560002
India |
| Phone |
8762542358 |
| Fax |
|
| Email |
medhaveeni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha A |
| Designation |
Professor |
| Affiliation |
Banglore medical college and research institute |
| Address |
Department of Pharmacology Banglore medical college and research institute
Bangalore
KARNATAKA
560002
India |
| Phone |
9886224085 |
| Fax |
|
| Email |
geethaanantharamaiah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Medhaveeni |
| Designation |
Junior resident |
| Affiliation |
Banglore medical college and research institute |
| Address |
Department of Pharmacology Banglore medical college and research institute
Bangalore
KARNATAKA
560002
India |
| Phone |
8762542358 |
| Fax |
|
| Email |
medhaveeni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self, Dr Medhaveeni, Junior resident, Department of Pharmacology, BMCRI, Bangalore, Karnataka, India- 560002 |
|
|
Primary Sponsor
|
| Name |
nil |
| 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 |
| Dr Medhaveeni |
Victoria hospital, BMCRI Bangalore |
OPD General Medicine, room no. 27, Victoria hospital, BMCRI Bangalore 560002
Bangalore
KARNATAKA |
8762542358
medhaveeni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Bangalore medical college and research institute, Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
tablet Telmisartan 40 mg OD alone versus tablet Telmisartan 40 mg OD plus Vitamin D supplementation |
Tablet Telmisartan 40 mg OD at night along with Vitamin D 60,000 IU sachets once per week to be mixed with milk or water and taken after breakfast for 8 weeks |
| Comparator Agent |
tablet Telmisartan 40 mg OD alone versus tablet Telmisartan 40 mg OD plus Vitamin D supplementation |
Tablet Telmisartan 40 mg OD at night for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written informed consent
Patients of either sex aged above 18 years and less than 60 years
Patients with newly diagnosed stage I essential hypertension as per JNC 8 guidelines BP more than 140 by 90 mmHg to less than 160 by 100 mmHg not on any antihypertensive medications
Patients with vitamin D insufficiency 25 OH D levels of 20 to 29 ng per mL |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mothers
Patients with secondary hypertension
Patients with any other co-existing medical illness such as type 2 diabetes mellitus, dyslipidemia, cardiac, pulmonary, renal and hepatic disorders
Patients who are on anticonvulsants, glucocorticoids, rifampicin, HAART therapy
Patients with hypersensitivity to study medication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mean reduction in systolic/diastolic blood pressure |
at baseline, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
26/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In my study, patients attending outpatient department of General medicine, Victoria hospital BMCRI will be assessed for eligibility criteria, written informed consent will be taken, demographic data, medical history, physical and clinical examination and baseline investigations will be done computer generated randomization will be done and participants will be assigned into two groups. Group A 42 participants on tablet Telmisartan 40 mg once daily and group B 42 participants on Telmisartan 40 mg once daily plus vitamin D 60,000 IU sachets once per week Participants will be followed up at the end of 4 weeks and 8 weeks and measurement of systolic and diastolic BP will be done. Relevant statistical tests, compiling of data will be done and study will be terminated. Further treatment will be continued according to treating physician’s decision |