Study of vitamin D therapy to improve heart function and immune response in patients with chronic kidney disease (CKD)

Impact of vitamin D supplementation on left ventricular mass on cardiac magnetic resonance imaging and immune regulation in chronic kidney disease: a randomised placebo-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN47936804

Enrollment

Registered

2011-04-05

Start date

2011-01-10

Completion date

Unknown

Last updated

2020-01-06

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

Conditions

Left ventricular hypertrophy (LVH) in patients with non-dialysis dependent chronic kidney disease (CKD stage 3b and 4) Circulatory System

Interventions

Oral cholecalciferol therapy 100,000 IU at week 0, 4, 8, 12, 24 and 42 or matching placebo.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 - 75 years with CKD stage 3b-4 2. Documented 25 hydroxy vitamin D defeciency/insufficiency with serum 25 (OH)D levels between 12.5 to 75 nmol/L 3. Left ventricular mass index (LVMI) between 80 - 160 g/m2 for females and 100 - 160 g/m2 for males 4. Patients on angiotensin converting enzyme inhibitors and/or angiotensin II receptor blockers

Exclusion criteria

Exclusion criteria: 1. Presence of diabetes mellitus (type I and II) 2. Serum calcium greater than 2.55 mmol/L 3. Anaemia (Hb less than 10.0 g/dL or taking regular erythropoiesis stimulating agents) 4. Known malignancy 5. History of congestive cardiac failure or ejection fraction less than 40% on ECHO and/or plasma NT-proBNP greater than 500 pg/ml 6. Uncontrolled hypertension (blood pressure [BP] greater than 150/90 mmHg despite anti-hypertensive medication) 7. Significant valvular heart disease identified on transthoracic ECHO 8 Conditions that may influence collagen metabolism such as recent (less than 6 months) surgery or trauma, fibrotic diseases or active inflammatory conditions 9. Immunosuppressive medications 10. Presence of arterio-venous fistula for dialysis access 11. History of previous myocardial infarction (Trop T greater than 0.5)

Design outcomes

Primary

Measure	Time frame
1. 10g improvement in left ventricular mass (LVM) with oral vitamin D therapy over 1 year 2. Difference in LVM in patients treated with vitamin D compared to controls Measured at 52 weeks from enrolment.	—

Secondary

Measure	Time frame
1. Reduction in cardiac fibrosis determined by biomarkers of cardiac fibrosis in serum post vitamin D3 therapy 2. Augmentation of adaptive immune response to Hepatitis B vaccination post oral vitamin D3 supplementation 3. Immune regulation with predominantly antiinflammatory response with oral vitamin D3 therapy 4. Measured at 52 weeks from enrolment.	—

Countries

United Kingdom

Outcome results

None listed

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