Effect of Vitamin D Replacement in Patients With Urolithiasis

NCT01349764 | Terminated DMC

• 1 other identifier: 10-325-BMB
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urolithiasis

Keywords

vitamin D replacement; Urolithiasis; deficiency; insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (1)

• The lithogenic effect of vitamin D replacement in terms of development of urolithiasis.

  24 months

Study Arms (2)

No vitamin D replacement

The control arm will not receive vitamin D replacement, but patients in both study arms will receive care consistent with best care practices for stone disease. All patients will be evaluated by the stone clinic clinical nutritionist and full nutritional evaluation will be performed. All patients will be advised to maintain adequate hydration (\>2L/day), no-added salt diet (Na 80-100mmol/day), low protein diet (1 g/kg/day). Patients with hyperoxaluria will be advised to follow low-oxalate diet. All patients will be advised to maintain moderate calcium intake; 800-1200mg/day.

Vitamin D3 tabs

The active arm of randomization will receive vitamin D repletion in the form of oral vitamin D3 tablets 10 000 IU twice/ week for 8 consecutive weeks, followed by a maintenance dose of 1 000 IU daily for further 22 months.

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

Vitamin D3 tabs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to the MUHC stone clinic and had inadequate vitamin D.

You may qualify if:

• OHD deficiency or insufficiency (defined as serum level \<75 nmol/L).
• History of urolithiasis (Calcareous stones).
• hour urinary calcium excretion \<7.5 mmol/day (normocalciuric).
• Low fracture risk (estimated by FRAX®, which was developed by WHO).

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Royal Victoria Hospital, McGill University Health Center

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sero Andonian, MD, FRCS (C)

  MUHC, Montreal QC, Canada

  PRINCIPAL INVESTIGATOR

• Ahsan Alam, MD, FRCP (C)

  MUHC, Montreal QC, Canada

  STUDY DIRECTOR

• Ramsey Sabbagh, MD, FRCP (C)

  MUHC, Montreal QC, Canada

  STUDY DIRECTOR

• Bernard Unikowsky, MD, FRCP (C)

  MUHC, Montreal QC, Canada

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 9, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

CA (1)