NCT01325610

Brief Summary

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 4, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

January 17, 2011

Last Update Submit

April 3, 2012

Conditions

Chronic Kidney DiseaseEnd Stage Renal DiseaseVitamin D Deficiency

Keywords

vitamin Dkidneyrenal

Outcome Measures

Primary Outcomes (1)

  • Vitamin D Status as measured by 25(OH)D levels

    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.

    12 weeks

Secondary Outcomes (1)

  • Calcium Absorption

    12 weeks

Interventions

cholecalciferolDIETARY_SUPPLEMENT

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

Also known as: Maximum D3, cholecalciferol, 10,000IU/capsule, 0.25mg USP, Pro-Pharma LLA, Kirksville, Mo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • on hemodialysis
  • \> 19 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

Related Publications (2)

  • Graeff-Armas LA, Kaufmann M, Lyden E, Jones G. Serum 24,25-dihydroxyvitamin D3 response to native vitamin D2 and D3 Supplementation in patients with chronic kidney disease on hemodialysis. Clin Nutr. 2018 Jun;37(3):1041-1045. doi: 10.1016/j.clnu.2017.04.020. Epub 2017 Apr 30.

    PMID: 28506446DERIVED

  • Armas LA, Zena M, Lund R, Heaney RP. Calcium absorption response to cholecalciferol supplementation in hemodialysis. Clin J Am Soc Nephrol. 2013 Jun;8(6):1003-8. doi: 10.2215/CJN.08610812. Epub 2013 Feb 14.

    PMID: 23411428DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Laura AG Armas, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 17, 2011

First Posted

March 30, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

April 4, 2012

Record last verified: 2012-04

Locations

US(1)