How Bone is Made in Children Receiving Dialysis
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ClinicalTrials.gov Identifier: NCT01799317 |
Recruitment Status : Unknown
Verified February 2013 by Isidro Salusky, MD, University of California, Los Angeles.
Recruitment status was: Recruiting
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
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Condition or disease | Intervention/treatment | Phase |
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Bone Mineralization Defect | Drug: Vitamin D2 | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Regulation of Bone Mineralization in Renal Osteodystrophy |
Study Start Date : | March 2009 |
Estimated Primary Completion Date : | June 2014 |
Estimated Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Treatment with vitamin D2
Vitamin D2 50,000u titrated to serum 25(OH)D values given orally once a month in addition to standard of care: Doxercalciferol escalating doses beginning at 2.5 mcg given orally thrice weekly. Sevelamer Carbonate 800 mg (1600- 4800 mg) given orally with each meal
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Drug: Vitamin D2
These patients will receive standard of care vitamin D 1,25 therapy with intervention of vitamin D2
Other Name: Ergocalciferol |
No Intervention: Standard of Care
Standard of Care: Doxercalciferol escalating doses beginning at 2.5 mcg given orally thrice weekly. Sevelamer Carbonate 800 mg (1600- 4800 mg) given orally with each meal
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- Improvement of bone mineralization defect demonstrated by bone histomorphometry [ Time Frame: 8 months ]Iliac crest bone biopsy pre and post treatment with vitamin D2
- Radiographic improvement of skeletal abnormalities associated with renal osteodystrophy [ Time Frame: 8 months ]We will compare skeletal lesions identified through radiographic studies with bone histomorphometry pre and post treatment with vitamin D2

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Ages Eligible for Study: | 6 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- medically stable patients
- 6-21 years old
- undergoing treatment with continuous cycling peritoneal dialysis
- evidence of mineralization defect and secondary hyperparathyroidism
Exclusion Criteria:
- histopathological lesion of bone such as adynamic bone or osteomalacia
- poor compliance
- current treatment with prednisone or other immunosuppressives
- treatment with human recombinant growth hormone
- parathyroidectomy

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): NCT01799317
Contact: Isidro Salusky, MD | 310.206.6987 | isalusky@mednet.ucla.edu |
United States, California | |
Loma Linda University | Recruiting |
Loma Linda, California, United States, 92354 | |
Contact: Shobbha Sahney, MD 909-558-8242 ssahney@llu.edu | |
Principal Investigator: Shobha Sahney, MD | |
Childrens Hospital Los Angeles | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Kevin Lemley, MD 323-361-2295 klemley@chla.usc.edu | |
Principal Investigator: Kevin Lemley, MD |
Principal Investigator: | Isidro Salusky, MD | University of California, Los Angeles |
Responsible Party: | Isidro Salusky, MD, Principal Investigator, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT01799317 |
Other Study ID Numbers: |
IBS-05 R01DK035423-19 ( U.S. NIH Grant/Contract ) |
First Posted: | February 26, 2013 Key Record Dates |
Last Update Posted: | February 26, 2013 |
Last Verified: | February 2013 |
Calcinosis Calcium Metabolism Disorders Metabolic Diseases Vitamin D Ergocalciferols Vitamins |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |