B-Vitamins and the Risk of total Mortality and Cardiovascular Disease in End-Stage Renal Disease.

Influence of water soluble vitamin supplementation on morbidity and mortality of patients with end-stage renal disease

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000911291

Enrollment

700

Registered

2006-01-16

Start date

2002-07-29

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

In observational studies hyperhomocysteinemia has been found to be associated with risk for total mortality and cardiovascular events in patients with end-stage renal disease. These patients have grossly elevated homocysteine levels that can be lowered by supplementation with folic acid and vitamin B12. We therefore conducted a randomized clinical trial with B-vitamins to reduce homocysteine levels and therefore also cardiovascular events and total mortality.

Interventions

watersoluble vitamins (combined study medication of folic acid 2.5 mg, vitamin B6 10 mg, vitamin B12 25(micro)g; two oral capsule taken three times a week after hemodiaylsis for the study duration (between 2 and 6 years) (the medication containes additionally vitamin B1 1.2mg, vitamin B2 1.5mg, Niacin 15 mg, Panothenic acid 6mg, Biotin 100(micro)g, Vitamin C 60mg)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

- age 20-80 years - end-stage renal disease - treatment with hemodialysis

Exclusion criteria

- addiction to drugs or alcohol - legal incapacity - missing consent - acute cardiovascular events (6 weeks before enrollment) - pregnancy and lactation

Outcome results