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Completed

NCT Number: NCT01325610

Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis

The assumption has been that 1,25(OH)2D is solely responsible for calcium absorption. That has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (CKD) (low 1,25(OH)2D leads to decreased calcium absorption, which increases parathyroid hormone release in compensation). Replacing 1,25 D directly has been the goal with using 1,25D or its analogues in CKD. There is very little data concerning use of native vitamin D or 25(OH)D in CKD, although autocrine functions in extrarenal tissues would use 25(OH)D. The latest KDIGO guidelines do recognize the autocrine role of vitamin D, but have no data on outcomes or doses or optimal levels to guide them and so have made a blanket recommendation to treat 25D levels in CKD by general healthy population guidelines.

1. This project focuses on an outcome (calcium absorption) that may be impacted by optimizing 25D status in renal patients. The investigators will assume for this project that a level of 25D > 32 ng/ml is optimal in CKD patients as in a healthy population. 2. A secondary outcome is to quantify calcium absorption in CKD patients with and without vitamin D repletion and to quantify systemic 1,25D levels. This may clarify the roles 25D and 1,25D play in calcium absorption.

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Key information

Conditions

Chronic Kidney Disease Avitaminosis Chronic Disease Deficiency Diseases Disease Attributes End Stage Renal Disease 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

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Creighton University

Omaha, Nebraska, 68131, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • on hemodialysis
  • > 19 years of age

Exclusion criteria

  • Pregnancy or planned pregnancy
  • Hypercalcemia (> 10.2 mg/dl) at baseline
  • Chronic GI disease
  • Liver dysfunction
  • Taking steroids
  • Received any investigational drugs within 4 weeks
  • Any allergy to vitamin D3
  • Chronic vitamin D intake > 1,000 IU daily
  • Dialysate concentration (calcium 2.5mg/L) which is to remain constant during Rx

Treatment and study plan

Cholecalciferol

Dietary Supplement

a weekly dose of 20,000 IU of vitamin D3 will be given orally for 12 weeks.

Other names: Maximum D3, cholecalciferol, 10,000IU/capsule, 0.25mg USP, Pro-Pharma LLA, Kirksville, Mo

Primary outcomes

  1. Vitamin D Status as measured by 25(OH)D levels

    Time frame: 12 weeks

    A weekly dose of 20,000 IU of vitamin D3 will be taken by the particpant and blood drawn to measure levels at weeks 1, 3, 5, 8, 10, 13, and 18.

Secondary outcomes

  1. Calcium Absorption

    Time frame: 12 weeks

    A calcium absorption test will be done at baseline and after 12 weeks of vitamin D treatment.

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • Dialysis Clinic, Inc.

Registry information

Official study title

The Effect of Oral Cholecalciferol (Vitamin D3) on Calcium Absorption in Persons on Long-term Hemodialysis

Acronym: NEPH-Cal-D

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 30, 2011
Registry last updated
Apr 4, 2012

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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