Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease - Full Text View

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

This study is currently recruiting participants.

Verified by Atlanta VA Medical Center, January 2009

First Received: October 28, 2008 Last Updated: January 14, 2009 History of Changes

Sponsored by:	Atlanta VA Medical Center
Information provided by:	Atlanta VA Medical Center
ClinicalTrials.gov Identifier:	NCT00781417

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:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease

Resource links provided by NLM:

Drug Information available for: Cholecalciferol Vitamin D

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 ]

Estimated Enrollment:	80
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
Placebo: Placebo Comparator Placebo	Other: Placebo Matching Placebo

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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, but less than 30 ng/ml, PTH level<110 pg/ml. 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: Emory University affiliated hospitals (including Emory University Hospital, VA Medical Center, Grady Memorial Hospital)
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, PTH level<110 pg/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, PTH level<110 pg/ml and who are able to provide written informed consent.
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

Contacts

Contact: Vin Tangpricha, MD, PhD

404-321-6111 ext 2080

vin.tangpricha@emory.edu

Locations

United States, Georgia
Atlanta VAMC	Recruiting
Atlanta, Georgia, United States, 30300
Contact: Vin Tangpricha, MD, PhD 404-321-6111 ext 2080 vin.tangpricha@emory.edu
Principal Investigator: Vin Tangpricha, MD, PhD

Sponsors and Collaborators

Atlanta VA Medical Center

Investigators

Principal Investigator:

Vin Tangpricha, MD, PhD

Emory University

More Information

No publications provided

Responsible Party:	Atlanta VA Medical Center ( Vin Tangpricha )
Study ID Numbers:	Atlanta VAMC
Study First Received:	October 28, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00781417 History of Changes
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

Study placed in the following topic categories:

Cholecalciferol
Parathyroid Diseases
Renal Insufficiency
Ergocalciferol
Ergocalciferols
Kidney Failure, Chronic
Endocrine System Diseases
Bone Density Conservation Agents
Trace Elements
Hormones
Hyperparathyroidism, Secondary
Vitamin D

Vitamin D2
Hyperparathyroidism
Urologic Diseases
Vitamin D3
Renal Insufficiency, Chronic
Vitamins
Neoplasm Metastasis
Calciferol
Micronutrients
Kidney Diseases
Endocrinopathy
Kidney Failure

Additional relevant MeSH terms:

Parathyroid Diseases
Cholecalciferol
Renal Insufficiency
Growth Substances
Physiological Effects of Drugs
Kidney Failure, Chronic
Ergocalciferols
Endocrine System Diseases
Bone Density Conservation Agents
Pharmacologic Actions

Hyperparathyroidism, Secondary
Vitamin D
Hyperparathyroidism
Urologic Diseases
Renal Insufficiency, Chronic
Vitamins
Micronutrients
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 01, 2009