Effect of vitamin D replacement in patients with chronic kidney disease

Randomised controlled trial to determine the effect of vitamin D replacement on arterial stiffness and cardiometabolic risk factors in vitamin D deficient stage 3-5 chronic kidney disease patients

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001113943

Enrollment

Registered

2011-10-25

Start date

2011-11-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Vitamin D deficiency is common in patients with chronic kidney disease and has been associated with increased risk of heart disease and death. Correcting vitamin D deficiency may improve risk for heart disease through its effects on blood vessel, immune and bone cell function. Stiffness of the arteries (arterial stiffness) is associated with increased risk of heart disease and can be measured using simple non-invasive methods. The effect of vitamin D replacement on arterial stiffness has not previously been studied in patients with kidney disease. This study will examine the effect of vitamin D, a commonly used over-the-counter medication, compared with placebo (“dummy tablet”) on blood vessel function in people with moderate to severe chronic kidney disease who are vitamin D deficient. In this study, you will be randomly assigned (”like flipping a coin”) to take either vitamin D or placebo (1 tablet monthly) for 6 months. If at 3 months, your vitamin D levels remain low, you may need to take the study medications every 2 weeks till the end of the study. Both the vitamin D and placebo medication will be supplied by a specialist compounding pharmacy with a state of the art compounding laboratory and is accredited by the Pharmacy Guild of Australia as a quality care pharmacy and as such operates under a quality care program. If you enter the full study, you will have blood tests and blood vessel function studies before you start and after you complete the study medication. During the study, you will not know which treatment you are on. Your other medications will remain constant. The study requires you to attend the Research Unit at Sir Charles Gairdner Hospital 4 times over a 6-month period.

Interventions

Group 1: 1 tablet is equivalent to 50,000U of cholecalciferol (Vitamin D3). Participants will be required to take 2 oral tablets at randomisation, then 1 oral tablet monthly for 6 months (24 weeks). Participants may be required to increase their dose to one tablet fortnightly between 3- 6 months if their 25OH-VitD blood level is less than 50 nmol/L at 3 months (12 weeks). Group 2 Placebo. The participants will be required to take the same number of oral placebo tablets as group one.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. ages 18-80 years 2. Vitamin D deficiency (25OHD 15- 75nmol/L) 3. Stage 3-5 CKD, not yet on dialysis (eGFRof < 60mL/min/m2)

Exclusion criteria

1.Serum Calcium > 2.55mmol/L and/ or Phosphate > 1.80mmol/L 2. Severe Calcium deficiency (<15nmol/L) 3. Liver enzymes (Bilirubin, alanine aminotransferase, GGT) > 3 times upper limit of normal 4. Cardiovascular event or unstable cardiovascular disease in preceding 6 months 6 or NYHA heart failure stage III or IV 5. Significant psychiatric disorder 6. Active infection or inflammation 7. Pregnancy/ planning pregnancy 8. Significant proteinuria (= to > 3g/d)

Outcome results