Effect of Vitamin D Replacement in Patients With Urolithiasis

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

When Vitamin D replacement is initiated in patients with history of urolithiasis, there will be higher incidence of hypercalciuria but with careful follow-up of these patients, hypercalciuria could be appropriately managed with thiazide diuretics so that the risk of newly diagnosed renal stones will be equivalent to control groups without Vitamin D replacements.the purpose of the study is to determine the effect of vitamin D replacement in patients with previous history of urolithiasis presenting to a tertiary stone clinic in terms of changes in 24-hour urine collection parameters and to evaluate the lithogenic effect of vitamin D replacement in terms of development of urolithiasis. Eighty-six eligible patients will be included in terms of having suboptimal vitamin D with history of calcareous urolithiasis and urinary calcium excretion <7.5 mmol/day. Patients will be randomly divided into 2 equal groups depending on whether they will receive vitamin D replacement with follow-up at 3, 6, 12, & 24 months.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 25-OHD deficiency or insufficiency (defined as serum level <75 nmol/L).

• History of urolithiasis (Calcareous stones).

• 24-hour urinary calcium excretion <7.5 mmol/day (normocalciuric).

• Low fracture risk (estimated by FRAX®, which was developed by WHO).

Exclusion Criteria:

• Age < 18 years

• Renal dysfunction (Serum creatinine concentrations of > 150 μmol/L).

• History of non-calcareous stones e.g. uric acid, cystine, or struvite stones.

• Hypercalcemia (serum ionized normalized calcium > 1.32 mmol/L)

• Patients with secondary hypercalciuria e.g. primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or active malignancy.

• Evidence of osteoporosis or intermediate/high fracture risk (estimated by FRAX).

• Patients taking drugs that could potentially affect urinary calcium excretion (vitamin D, calcium supplement, loop diuretics, steroids, or lithium).

• Evidence of liver dysfunction or other disorders that may cause non-nutritional vitamin D deficiency or abnormal bone development.

• Pregnancy or lactation.