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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:
ClinicalTrials.gov Identifier:
NCT00781417
First Posted: October 29, 2008
Last Update Posted: February 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Emory University
Information provided by (Responsible Party):
Vin Tangpricha, Atlanta VA Medical Center
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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:


Further study details as provided by Vin Tangpricha, Atlanta VA Medical Center:

Primary Outcome Measures:
  • 25(OH)D [ Time Frame: 52 weeks ]
  • Parathyroid Hormone [ Time Frame: 52 weeks ]
  • 24 hour urine calcium [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • Markers of bone turnover [ Time Frame: 52 weeks ]

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Vin Tangpricha, Associate Professor, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00781417     History of Changes
Other Study ID Numbers: Atlanta VAMC
First Submitted: October 28, 2008
First Posted: October 29, 2008
Last Update Posted: February 7, 2012
Last Verified: February 2012

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

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


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