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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Thalassemia Major

In brief

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.

Key facts

Study ID

NCT01323608

Run by

Weill Medical College of Cornell University

People needed

40

Starts

2011-06-01

Expected to finish

2014-12-01

Last updated by the study team

2011-04-19

Who can join

Age: 6 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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