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Add on therapy of Vitamin D3 sublingual tablets for treatment of Hypertension

Utility of sublingual vitamin D3 as an add on therapy in patients of hypertension- A open label non-randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008033
Enrollment
400
Registered
2017-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Essential Hypertension Health Condition 2: Z798- Other long term (current) drug therapy

Interventions

Intervention1: Vitamin D3(Cholecalciferal)60000IU Sublingual TabletsTablets: Dose: 60,000 IU 1 Tablets/Week, 4-5 Tablets/One month, Total duration 3 months / 24Tab Route: Sublingually Control Inte

Sponsors

Rural Medical College
Lead Sponsor
Duram Pharmachem PVT LTD
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All the patients of Essential hypertension taking Antihypertensive drugs since last Three months. All the patients of Essential hypertension with or without Renal dysfunction. All the patients of Essential hypertension on Antihypertensive drugs with or without Vitamin D3 add on therapy. Adult patients between 18-60 years. Patients of either sex. Patients willing to participate in study. Ready to give written informed consent.

Exclusion criteria

Exclusion criteria: Patient suffering from Gestational hypertension. Patients of hypertension on thiazide diuretics (Hypercalcemia). Patients with history of any tumours and Patients on medication which may lead to hypercalcemia. Patients suffering from hypertension with CVS, Brain disorders. Patients suffering from chronic illness. Patients suffering from genetic disorders, hyperparathyroidism, taking antieplieptics . Patients on chronic medications other than antihypertensive.

Design outcomes

Primary

MeasureTime frame
Changes in systolic and diastolic Blood pressure, Mean BP and Pulse pressureTimepoint: Every 15 days from the date of baseline visit to procure 6 readings of Blood pressure at an interval of 15days (Total Follow-up 6 after the first visit ) every 15 Days followup. Total time 3 months.

Secondary

MeasureTime frame
Renal Function test Serum Vitamin D3 levels Adverse effects Timepoint: RFT and serum Vitamin D3 levels at baseline visit and at the last visit at 90 days Adverse effects monitoring at every 15 days

Countries

India

Contacts

Public ContactSanjeeva Kumar Goud T

Pravara Institute of Medical Sciences

director.research@pmtpims.org7208198806

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026