Vitamin D Supplementation and Cardiac Hypertrophy in Chronic Kidney Disease (CKD)

NCT01323712 | Unknown Phase 2 DMC

• 2 other identifiers: BHF PG/10/71/28462PG/10/71/28462
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with Chronic Kidney Disease (CKD) are upto 3.5 times more likely to die from diseases of heart and blood vessels (Cardiovascular Disease-CVD). Vitamin D insufficiency is very common in CKD and associated with CVD. Animal studies have shown an improvement in heart size and function with Vitamin D therapy, although evidence in humans is lacking. The proposed study will test if oral Vitamin D treatment, in deficient CKD patients, will improve heart enlargement and function. With these proposed changes the investigators expect to reduce CVD and deaths in patients with CKD.

Conditions

Chronic Kidney Disease

Keywords

CKD; LV mass; Vitamin D; LV function

Outcome Measures

Primary Outcomes (1)

• Left ventricular mass

  52 weeks

Secondary Outcomes (1)

• Cardiac systolic and diastolic function

  52 weeks

Study Arms (1)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Vitamin D Cholecalciferol

Interventions

Vitamin D Cholecalciferol DIETARY_SUPPLEMENT

Cholecalciferol 100,000 Units 6 doses; 0,4,8,12,24,42 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult (18-75 years old)
• patients with estimated GFR between 15-45 ml/min/1.73 m2 (CKD stage 3b and 4) on ACE inhibitors and/or ARB therapy will be recruited.

You may not qualify if:

• The following patients will be excluded from the trial:
• patients with diabetes mellitus
• Hb \< 10gm% or on EPO
• serum calcium \> 2.55 mmol/L
• known malignancies
• patients on vitamin D supplementation
• heart failure (ejection fraction \< 40 or pro NT BNP \> 500 pg/ml
• uncontrolled hypertension (BP \> 150/90 mmHg)
• patients with AV fistula for dialysis access
• significant valvular heart disease
• conditions that may influence collagen metabolism such as recent (\< 6months) surgery or trauma
• fibrotic diseases or active inflammatory conditions
• history of myocardial infarction and/or Troponin T \> 0.5

Sponsors & Collaborators

• St George's, University of London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (2)

Guy's and St Thomas' NHS Foundation Trust

London, London, United Kingdom

Location

Debasish Banerjee

London, Tooting, sw17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Debasish Banerjee, MD FRCP

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: March 28, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

GB (2)