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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  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:


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.

  Show Detailed Description

  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
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: 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 July 20, 2014