Can high-dose vitamin D supplementation reduce blood pressure and markers of cardiovascular risk in older people with isolated systolic hypertension? - Vitamin D in ISH

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004534-24-GB

Enrollment

180

Registered

2008-10-16

Start date

2008-11-18

Completion date

Unknown

Last updated

2017-04-03

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

Conditions

Isolated systolic hypertension MedDRA version: 9.1 Level: LLT Classification code 10050591 Term: Isolated systolic hypertension

Interventions

Trade Name: Vigantol Product Name: Cholecalciferol Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age > or = 70 yrs Office systolic BP > or = 140 mmHg Serum 25 Hydroxy vitamin D =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Hypertension known to be due to a correctable underlying medical or surgical cause Diastolic blood pressure >90mmHg Systolic blood pressure >180mmHg Estimated glomerular filtration rate 3x normal Corrected calcium >2.60 mmol/L or <2.15 mmol/L Known metastatic malignancy or sarcoidosis Clinical diagnosis of osteomalacia History of renal calculi Diagnosis of heart failure with left ventricular systolic dysfunction. Atrial fibrillation Already taking vitamin D supplements. Consumption of fish oils will not be a contraindication to enrolment Unable to give written informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To test whether high dose vitamin D3 can improve blood pressure in patients aged 70 and over with isolated systolic hypertension;Secondary Objective: To test whether high dose vitamin D3 can improve markers of vascular health including endothelial function, arterial stiffness and b-type natriuretic peptide in patients aged 70 and over with isolated systolic hypertension;Primary end point(s): Change in office blood pressure at 3 months	—

Measure

Time frame

Main Objective: To test whether high dose vitamin D3 can improve blood pressure in patients aged 70 and over with isolated systolic hypertension;Secondary Objective: To test whether high dose vitamin D3 can improve markers of vascular health including endothelial function, arterial stiffness and b-type natriuretic peptide in patients aged 70 and over with isolated systolic hypertension;Primary end point(s): Change in office blood pressure at 3 months

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Countries

United Kingdom

Outcome results

None listed

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