NCT00511225

Brief Summary

Will oral vitamin improve strength, bone quality, pain and quality of life. This is a double blind, randomized placebo controlled study using 10,000 IU of cholecalciferol vs placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 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

August 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2007

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 3, 2012

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

August 1, 2007

Last Update Submit

June 29, 2012

Conditions

End Stage Renal Disease

Keywords

dialysisVitamin D

Outcome Measures

Primary Outcomes (1)

  • change in physical performance score

    15 weeks

Secondary Outcomes (3)

  • Bone pain and tenderness

    15 weeks

  • Neuromuscular function tests

    15 weeks

  • Quality of life assessment

    15 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Will receive 10,000 IU of cholecalciferol weekly

Dietary Supplement: cholecalciferol

2

PLACEBO COMPARATOR

Will receive a identical appearing placebo weekly

Dietary Supplement: placebo

Interventions

cholecalciferolDIETARY_SUPPLEMENT

10,000 IU weekly

Also known as: Maximum D3®,Pro-Pharma LLA, Kirksville, MO
1
placeboDIETARY_SUPPLEMENT

placebo capsule

2

Eligibility Criteria

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

You may qualify if:

  • On dialysis
  • Likely to be able to complete the study
  • At least minimally ambulatory, with or without a walking aid (i.e., cane or walker)
  • Able to complete the various questionnaires interactively with the research nurse
  • Venous access that can be accomplished without unusual difficulty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, 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, Andukuri R, Barger-Lux J, Heaney RP, Lund R. 25-Hydroxyvitamin D response to cholecalciferol supplementation in hemodialysis. Clin J Am Soc Nephrol. 2012 Sep;7(9):1428-34. doi: 10.2215/CJN.12761211. Epub 2012 Jul 12.

    PMID: 22798536DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Richard Lund, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 3, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2010

Study Completion

September 1, 2011

Last Updated

July 3, 2012

Record last verified: 2012-06

Locations

US(1)