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Completed

NCT Number: NCT01029002

The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease

A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.

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Key information

Conditions

Chronic Renal Insufficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montefiore medical center

The Bronx, New York, 10467, United States

About this study

This RCT will enroll 74 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals.

Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.

Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.

There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.

Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 years
  • Ability to provide informed consent
  • Chronic kidney disease stage 3 and 4
  • On ACE inhibitor or ARB for albuminuria if tolerated
  • Assessed during eligibility screen:
  • Albuminuria >30 mg/g creatinine
  • 25(OH) vitamin D level >12.5 and <75 nmol/L

Exclusion criteria

  • On vitamin D in past 4 weeks
  • Plans to relocate out of New York City in the next 6 months
  • 25 (OH) Vitamin D level <12.5 nmol/L
  • HIV infection
  • History of hypercalcemia or kidney stones
  • Serum phosphate >5.5 mg/dl in past 3 months
  • Serum calcium >10.0 mg/dl in past 3 months
  • SBP >160 DBP >100 at screening visit
  • Transplanted organ
  • Cancer
  • Polycystic kidney disease
  • Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months

Treatment and study plan

Vitamin D

Drug

Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months

Placebo

Other

Patients randomized to this arm will receive one placebo pill once weekly.

Primary outcomes

  1. Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.

    Time frame: 3 months

    Urine albumin and creatinine were measured on spot urine specimens.

Secondary outcomes

  1. Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome.

    Time frame: 3 months

    25(OH) vitamin D levels were measured using liquid chromatography.

  2. Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2009
Registry last updated
Aug 16, 2023

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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