Impact of Vitamin D on Diabetic Kidney Disease in African Americans

NCT01214356 | Completed Results

• 1 other identifier: 1R03DK089120
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This purpose of this project is to evaluate the effectiveness of vitamin D supplementation over 12 months in vitamin D deficient African American adults with type 2 diabetes.

Conditions

Diabetic Kidney Disease

Keywords

diabetes; kidney disease; vitamin D

Outcome Measures

Primary Outcomes (1)

• Change in Urinary Albumin:Creatinine Ratio (ACR)

  Urinary Albumin:Creatinine Ratio (ACR) is a well-established, sensitive marker of nephropathy progression (urine albumin (mg/dL) to urine creatinine (g/dL) ratio).

  baseline and 6 months

Secondary Outcomes (1)

• Decrease in Estimated Glomerular Filtration Rate (eGFR)

  6 months

Study Arms (2)

Lower Dose Vitamin D

PLACEBO COMPARATOR

Vitamin D3 supplementation of 400 IU/D or 4000 IU/D with combined calcium carbonate supplementation of 1000 mg/day

Dietary Supplement: Vitamin D3

Higher Dose Vitamin D

ACTIVE COMPARATOR

Vitamin D3 supplementation of 4000 IU/D or 4000 IU/D with combined calcium carbonate supplementation of 1000 mg/day

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Patients receive vitamin D 400 IU/d with calcium carbonate (1000 mg) once per day for 15 months (3 month run in phase with 12 month follow up)

Also known as: Cholecalciferol

Lower Dose Vitamin D

Eligibility Criteria

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

You may qualify if:

• African American race
• Diagnosis of Type 2 Diabetes
• Stage 1 or 2 Kidney Disease with detectable microalbuminuria \>4.0 (mg/g) 25(OH)D level \<20 ng/ml

You may not qualify if:

• Type 1 diabetes
• \> Stage 3 Kidney Disease, or history of dialysis, kidney transplantation or nephrolithiasis
• Unable to provide informed consent or contact information
• Pre-existing calcium or parathyroid condition, including serum calcium \>10.2 mg/dL
• Sarcoidosis, active tuberculosis, or malignancy
• Known hypersensitivity to vitamin D or any of its analogues and derivatives
• Current pregnancy or planning to become pregnant in next 15 months

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus; Kidney Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

small sample size, loss to follow up

Results Point of Contact

• Title: Vanessa Diaz, MD MSCR
• Organization: MUSC

diazva@musc.edu

8438762923

Study Officials

• Vanessa A Diaz, MD, MS

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 5, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-09

Locations

US (1)