NCT00781417

Brief Summary

This study will evaluate whether earlier intervention with vitamin D in stage II/III chronic kidney disease will prevent or delay secondary hyperparathyroidism. Subjects will receive vitamin D or placebo at study entry and will be followed for a period of one year. The hypothesis is that subjects given vitamin D will have lower PTH and higher 25(OH)D after 1 year compared to placebo. Additionally, there will be less subjects who progress into secondary hyperparathyroidism in the vitamin D treated group compared to the placebo treated group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration 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

Study Start

First participant enrolled

October 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

3 years

First QC Date

October 28, 2008

Last Update Submit

February 4, 2012

Conditions

Kidney Disease

Keywords

vitamin DChronic Kidney Diseaseparathyroid hormoneChronic kidney disease Stage II and III

Outcome Measures

Primary Outcomes (3)

  • 25(OH)D

    52 weeks

  • Parathyroid Hormone

    52 weeks

  • 24 hour urine calcium

    52 weeks

Secondary Outcomes (1)

  • Markers of bone turnover

    52 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Cholecalciferol 50,000 IU once a week for 12 weeks then every other week for 40 weeks

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

50,000 IU once a week for 12 weeks then every other week for 40 weeks

Also known as: cholecalciferol, vitamin D3
1
PlaceboOTHER

Matching Placebo

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study subjects must be patients with CKD stage II/III (estimated glomerular filtration rate, 30-90 ml/min/1.73m body surface area), 25-hydroxyvitamin D (25(OH) D) level \>10 ng/ml documented in the medical record for the past 6 months.
  • Estimated Glomerular Filtration Rate will be calculated by using the original Modification of Diet in Renal Disease Study equation (online at http://www.nkdep.nih.gov)(16)
  • Study subjects must agree to participate in the study and provide written informed consent
  • Histology: not applicable
  • Sites: Atlanta VA Medical Center
  • Stage of Disease: CKD stage II/III, who has 25-hydroxyvitamin D (25(OH)D) level \>10 ng/ml, but less than 30 ng/ml
  • Age: Study subjects must be \>18 but \<85 years old
  • Performance Status: Study subjects will be patients with CKD stage II/III (estimated glomerular filtration rate, 30-90 ml/min/1.73m body surface area), 25-hydroxyvitamin D (25(OH)D) level \>10 ng/ml, but less than 30 ng/ml
  • Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English.

You may not qualify if:

  • Age \< 18years or \>85 years old
  • Prior other diseases: History of liver failure (AST or ALT \>3 ULN), history of intestinal malabsorption or chronic diarrhea, corrected serum calcium \>10.5 mg/dl, calcium x phosphorus product \>70,treatment with more than 1000 IU of vitamin D per day; or current treatment with a vitamin D analogue or calcimimitec, taking antiepileptic medication, or other medications that could alter vitamin D metabolism(eg, phenytoin, phenobarbital, rifampin(17)
  • Infection: not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VAMC

Atlanta, Georgia, 30300, United States

Location

MeSH Terms

Conditions

Kidney DiseasesRenal Insufficiency, Chronic

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Vin Tangpricha, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 29, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

US(1)