Vitamin D Repletion in Stone Formers With Hypercalciuria

NCT01295879 | Completed Phase 4 Results

• 1 other identifier: AAAF3346
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D plays a critical role in maintaining bone health, as well as preventing cardiovascular disease, cancer, and various autoimmune diseases, such as diabetes. Vitamin D deficiency is very common in the United States and worldwide, and is now being increasingly recognized and treated. One group in which vitamin D deficiency may be particularly important is patients who have had kidney stones. These patients frequently have elevated levels of calcium in their urine, which is a common and important risk factor for calcium containing kidney stones. Because vitamin D increases absorption of calcium into the blood by the intestines, physicians may be reluctant to prescribe vitamin D therapy to patients with vitamin D deficiency if they also have kidney stones and high amounts of calcium in the urine. They are concerned about the possible risk of increasing the amount of calcium in the urine (and thereby increasing the risk of calcium stones occurring again). However, studies in patients without kidney stones, as well as studies in patients with high calcium levels in the urine, have demonstrated that giving vitamin D is effective and safe and does not increase calcium in the urine. Therefore, the investigators will study the effects of giving vitamin D on the amount of calcium in the urine in patients with a history of kidney stones and elevated calcium in the urine. The investigators will evaluate the safety of giving vitamin D to this particular group of patients.

Conditions

Nephrolithiasis; Urolithiasis; Idiopathic Hypercalciuria; Vitamin D Deficiency; Disorder of Vitamin D

Keywords

Vitamin D insufficiency

Outcome Measures

Primary Outcomes (1)

• Change in 24 Hour Urine Calcium

  Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones

  8 weeks

Secondary Outcomes (2)

• Change in 24 Hour Urine Supersaturation of Calcium Oxalate

  8 weeks

• Recurrence of Kidney Stones

  8 weeks

Study Arms (1)

Ergocalciferol

EXPERIMENTAL

Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks

Drug: Ergocalciferol

Interventions

Ergocalciferol DRUG

Ergocalciferol 50,000 IU's orally per week, for 8 weeks

Also known as: Vitamin D2

Ergocalciferol

Eligibility Criteria

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

You may qualify if:

• History of nephrolithiasis as per medical record
• Urinary calcium excretion between 150 and 400 mg/day (measured within 3 months of study enrollment)
• (OH)D deficiency or insufficiency (defined as a serum level \< 30 ng/ml) within 3 months of enrollment

You may not qualify if:

• Pregnant women, since the optimal dose of vitamin D supplementation in this population has not been rigorously studied.
• Known uric acid, cystine, or struvite stone disease (because our intervention is predominantly aimed at patients with calcium stone disease). An exception to this is patients who have passed both uric acid and calcium stones, or patients who have passed stones of mixed composition (uric acid and calcium).
• Hypercalcemia (serum calcium \> 10.4 mg/dL) at baseline
• Acute stone event or gross hematuria (blood in the urine) within the past 2 months
• Recent stone intervention within the past 1 month
• Suspected or known secondary causes of hypercalciuria, such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except nonmelanoma skin cancer)
• Addition or dose change of medicines potentially affecting urinary calcium since the baseline 24hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)

Sponsors & Collaborators

• New York Presbyterian Hospital: lead

Study Sites (1)

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Nephrolithiasis; Urolithiasis; Vitamin D Deficiency

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David E. Leaf, M.D., Renal Fellow
• Organization: Brigham and Women's Hospital

DELEAF@partners.org

617-732-5951

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology Fellow

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 23, 2012
• Results First Posted: October 23, 2012

Record last verified: 2012-09

Locations

US (1)