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Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease (POSH-D)

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Vin Tangpricha, Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT00781417
First received: October 28, 2008
Last updated: February 4, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Kidney Disease
 Dietary Supplement: Vitamin D
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Atlanta VA Medical Center:

Primary Outcome Measures:
  • 25(OH)D [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Parathyroid Hormone [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 24 hour urine calcium [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Markers of bone turnover [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cholecalciferol 50,000 IU once a week for 12 weeks then every other week for 40 weeks
 Dietary Supplement: Vitamin D
50,000 IU once a week for 12 weeks then every other week for 40 weeks
Other Names:
  • cholecalciferol
  • vitamin D3
Placebo Comparator: Placebo
Placebo
 Other: Placebo
Matching Placebo
Other Name: placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781417

Locations
United States, Georgia
Atlanta VAMC
Atlanta, Georgia, United States, 30300
Sponsors and Collaborators
Atlanta VA Medical Center
Emory University
Investigators
Principal Investigator: Vin Tangpricha, MD, PhD Emory University
  More Information

No publications provided

Responsible Party: Vin Tangpricha, Associate Professor, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00781417     History of Changes
Other Study ID Numbers: Atlanta VAMC
Study First Received: October 28, 2008
Last Updated: February 4, 2012
Health Authority: United States: Federal Government

Keywords provided by Atlanta VA Medical Center:
vitamin D
Chronic Kidney Disease
parathyroid hormone
Chronic kidney disease Stage II and III

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
 Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013