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The Effect of Vitamin D Supplementation on Calcium Excretion in Thalassemia: a Dose Response Study

This study is not yet open for participant recruitment.
Verified April 2011 by Weill Medical College of Cornell University
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01323608
First received: March 24, 2011
Last updated: April 18, 2011
Last verified: April 2011
History of Changes
  Purpose

The purpose of this pilot study is to determine the effect of various doses of vitamin D supplementation on vitamin D stores and calcium excretion in the urine in subjects with Thalassemia Major (TM). Subjects with TM are routinely placed on vitamin D supplements because they frequently have osteoporosis (a condition in which bone tissue thins and loses density and strength) and low vitamin D stores. The amount of vitamin D supplementation that is required to raise vitamin D stores in optimal levels is not known in TM, and will be determined in this study. Finally, a recent study in TM has linked blood vitamin D levels to urine calcium excretion, which is a risk factor for kidney stones. Therefore, we want to determine changes in calcium excretion with various vitamin D doses and with increasing vitamin D stores. We plan to test 3 doses of vitamin D for 3 months in children and adults with TM. Changes in vitamin D blood levels and urinary calcium will be determined. The results of this pilot study will be used in future studies that will examine the effect of various doses of vitamin D supplementation in the treatment of osteoporosis in TM.


Condition Intervention Phase
Thalassemia Major
 Drug: Vitamin D3
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effect of Vitamin D Supplementation on Calcium Excretion in Thalassemia: a Dose Response Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Vitamin D Dose Response Curve [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
    To perform a dose response curve for vitamin D supplementation study and determine the relationship between vitamin D doses and serum 25OHD concentrations and urinary calcium excretion in children and adults with TM.


Secondary Outcome Measures:
  • Vitamin D Dose Response Curve [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
    To determine changes in serum calcium and PTH concentrations with various vitamin D doses


Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo
Experimental: Low Vitamin D Group
Subjects in this group will receive the equivalent of 400 IU/day.
 Drug: Vitamin D3
Vitamin D3 will be given at the equivalent of the following doses: 400, 1000, and 2000 IU/day.
Experimental: Intermediate Vitamin D group Drug: Vitamin D3
Vitamin D3 will be given at the equivalent of the following doses: 400, 1000, and 2000 IU/day.
Experimental: High Vitamin D Group Drug: Vitamin D3
Vitamin D3 will be given at the equivalent of the following doses: 400, 1000, and 2000 IU/day.

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  Eligibility

Ages Eligible for Study:   6 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Thalassemia Major (TM)
  • 25 OHD: 15-29 ng/ml
  • Age 6 to 60 years
  • Albumin corrected serum Calcium: Normal (8.5-10.5 mg/dl)

Exclusion Criteria:

  • Other thalassemia syndromes
  • 25 OHD concentrations < 15 ng/ml or ≥30 ng/ml
  • Subjects younger than 6 years
  • Hypoparathyroidism
  • Abnormal albumin corrected serum Ca (i.e. total calcium <8.5 or > 10.5 mg/dl)
  • Medications that may adversely affect vitamin D metabolism (anticonvulsants) or absorption
  • End stage renal, heart, or liver disease
  • History of Nephrolithiasis or Nephrocalcinosis
  • Diseases associated with hypercalciuria (ie. Sarcoidosis, Cushing syndrome, and Wilson disease to name a few)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323608

Contacts
Contact: Maria Vogiatzi, MD 212-746-3462 mvogiatz@med.cornell.edu
Contact: Patricia J Giardina, MD 212-746-3415 pjgiardi@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Not yet recruiting
New York, New York, United States, 10065
Contact: Maria Vogiatzi, MD     212-746-3462     mvogiatz@med.cornell.edu    
Contact: Patricia J Giardina, MD     212-746-3415     pjgiardi@med.cornell.edu    
Principal Investigator: Maria Vogiatzi, MD            
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Maria Vogiatzi, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Maria Vogiatzi, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT01323608     History of Changes
Other Study ID Numbers: 1102011521
Study First Received: March 24, 2011
Last Updated: April 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Thalassemia
hypercalciuria
vitamin D
To conduct a pilot study to determine the effect of various doses of
vitamin D supplementation on vitamin D stores and their association with calcium excretion

Additional relevant MeSH terms:
Beta-Thalassemia
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Cholecalciferol
 Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 22, 2013