Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease

Completed · Not applicable · Has a placebo group

Conditions studied: Kidney Disease

In brief

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.

Key facts

Study ID

NCT00781417

Run by

Atlanta VA Medical Center

People needed

48

Starts

2008-10-01

Expected to finish

2011-12-01

Last updated by the study team

2012-02-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Atlanta VAMC — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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