Vitamin D Repletion in Chronic Kidney Disease

NCT00772772 | Completed Early Phase 1 Results

• 1 other identifier: MAP-0626
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The reason for doing this research is that people with kidney disease often suffer from heart disease. Why this happens is not fully known. A possible cause may be high blood levels of a substance made by bacteria called "endotoxin". The blood levels of this substance are high in people with medium-level kidney disease. We want to know if replacing normal amounts of Vitamin D can help lower the levels of this substance. We also want to know if replacing normal amounts of Vitamin D is associated with other changes that may help heart disease. We hope that our research will help figure out if levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal subjects are enrolled to have a 'control' set for comparison purposes.

Conditions

Chronic Kidney Disease

Keywords

Vitamin D3 repletion; levels of endotoxin; intestinal permeability; accelerated atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Change in Endotoxin Activity

  Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).

  baseline and 8 weeks

Secondary Outcomes (5)

• Blood Pressure

  after 8 weeks of vitamin D therapy

• Intestinal Permeability

  after 8 weeks of vitamin D therapy

• Nuclear Magnetic Resonance (NMR) Lipoprotein Profile

  after 8 weeks of vitamin D therapy

• 25-hydroxy Vitamin D (25-OH Vitamin D)

  after 8 weeks of vitamin D therapy

• 1, 25-OH Vitamin D

  after 8 weeks of vitamin D therapy

Study Arms (1)

Vitamin D3

EXPERIMENTAL

Vitamin D3 30,000 international units orally per week for 8 weeks

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

2 single oral dose of Vitamin D3 30,000 international units and 8 weeks supply of Vitamin D3 (10,000 IU tablets, 3 pills to be taken by mouth as one dose weekly)

Also known as: Vitamin D

Vitamin D3

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and post-menopausal females, between the age of 50 -80.
• Vitamin D 25-OH level less than 20 ng/ml
• Males and post-menopausal females, between the age of 50 -80.
• Chronic kidney disease stage 3
• Vitamin D 25-OH level less than 20 ng/ml

You may not qualify if:

• Serum calcium level \>10.5 mg/dl
• Serum phosphorus level \> 5.5 mg/dl
• Serum PTH level \< 35 pg/ml
• Active infection including HIV, Hepatitis B or C
• History of recent acute infection ( within 1 month)
• Gastrointestinal disease resulting in significant GI dysfunction or malabsorption
• Hgb\< 10 g/dL
• Current use of Coumadin
• Current use of Vitamin D \>400 IU/day
• Current use of systemic steroids or other immunosuppressants
• History of malignancy not in remission (\>6 months)
• History of current ethanol abuse or illicit drug use
• History of significant emotional disorder within the past 5 years
• Participation in an investigational drug study within one month of screening
• Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Mansih Ponda
• Organization: The Rockefeller University

mponda@rockefeller.edu

212-327-7631

Study Officials

• Manish Ponda, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Investigation

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 15, 2015
• Results First Posted: June 13, 2011

Record last verified: 2015-01

Locations

US (1)