Phase 3 N=74 Randomized Quadruple-blind Treatment

The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease

Chronic Renal Insufficiency · Proteinuria

Bottom Line

View on ClinicalTrials.gov: NCT01029002 ↗

Enrolled (actual)

Serious AEs

39.2%

Results posted

Aug 2023

Primary outcome: Primary: Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures. — 1126.68; 1061.39 mg/gram creatinine

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Vitamin D (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Albert Einstein College of Medicine
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.	1126.68; 1061.39	—
SECONDARY Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome.	29.9; 17.1	—
SECONDARY Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome.	—	—

Summary

A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.

Eligibility Criteria

Inclusion Criteria

Age >18 years
Ability to provide informed consent
Chronic kidney disease stage 3 and 4
On ACE inhibitor or ARB for albuminuria if tolerated
Assessed during eligibility screen:
Albuminuria >30 mg/g creatinine
25(OH) vitamin D level >12.5 and 5.5 mg/dl in past 3 months
Serum calcium >10.0 mg/dl in past 3 months
SBP >160 DBP >100 at screening visit
Transplanted organ
Cancer
Polycystic kidney disease
Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01029002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.