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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 29, 2014