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OpenTrials
Completed

NCT Number: NCT01312714

Vitamin D3 Supplementation in Dialysis Patients

Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated with cardiovascular risk factors such as increased aortic pulse wave velocity, blood pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of 26 weeks of vitamin D3 supplementation in patients with end stage renal disease.

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Key information

Conditions

End-stage Renal Disease Avitaminosis Chronic Disease Deficiency Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Departments of Medical Research and Medicine, Holstebro Hospital

Holstebro, 7500, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemodialysis or peritoneal dialysis > 3 months

Exclusion criteria

  • Hypercalceamia
  • Cancer
  • Inability to give informed consent

Treatment and study plan

Cholecalciferol

Drug

3 tablets of 1000 IU daily for 26 weeks

Other names: Vitamin D3

Placebo

Drug

3 tablets of 1000 IU daily for 26 weeks

Primary outcomes

  1. Plasma concentration of NT-proBNP

    Time frame: 26 weeks

Secondary outcomes

  1. Plasma concentration of ionized calcium

    Time frame: 4 weeks

  2. Plasma concentration of phosphate

    Time frame: 4 weeks

  3. Plasma concentration of PTH

    Time frame: 4 weeks

  4. Plasma concentration of 25-hydroxycholecalciferol

    Time frame: 4 weeks

  5. 24-hour blood pressure

    Time frame: 26 weeks

  6. Plasma renin concentration

    Time frame: 26 weeks

  7. Plasma concentration of angiotensin II

    Time frame: 26 weeks

  8. Plasma concentration of aldosterone

    Time frame: 26 weeks

  9. Arterial stiffness

    Time frame: 26 weeks

  10. Serum concentration of FGF-23

    Time frame: 26 weeks

  11. Plasma concentration of AVP

    Time frame: 26 weeks

  12. Plasma concentration of ANP

    Time frame: 26 weeks

  13. Plasma concentration of TNF alpha

    Time frame: 26 weeks

  14. Heart Function

    Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

A Randomized, Placebo-Controlled, Double Blind Study Evaluating the Effect of Cholecalciferol on Vasoactive Hormones, Heart Function, Arterial Stiffness, and Blood Pressure in Dialysis Patients.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 11, 2011
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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