Vitamin D Repletion in Chronic Kidney Disease

• Sponsor: Rockefeller University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00772772
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 19
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Drug: Vitamin D3	Early Phase 1

Detailed Description

Your participation in this study requires:

• 4 visits to the outpatient clinic (including 1 screening visit)

• Providing a blood sample (less than 5 tablespoons) and a urine sample at each visit

• Taking a test to measure how leaky your gut is. This test requires that you drink a small amount of liquid (about 4 ounces) and then collect your urine for 6 hours after drinking the liquid.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D3 Vitamin D3 30,000 international units orally per week for 8 weeks	Drug: Vitamin D3; 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); Other Names: Vitamin D

Outcome Measures

Primary Outcome Measures

1. Change in Endotoxin Activity [baseline and 8 weeks]

   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).

Secondary Outcome Measures

1. Blood Pressure [after 8 weeks of vitamin D therapy]

2. Intestinal Permeability [after 8 weeks of vitamin D therapy]

3. Nuclear Magnetic Resonance (NMR) Lipoprotein Profile [after 8 weeks of vitamin D therapy]

4. 25-hydroxy Vitamin D (25-OH Vitamin D) [after 8 weeks of vitamin D therapy]

   25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly.

5. 1, 25-OH Vitamin D [after 8 weeks of vitamin D therapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Inclusion Criteria for Healthy volunteers

• Males and post-menopausal females, between the age of 50 -80.

• Vitamin D 25-OH level less than 20 ng/ml

Inclusion Criteria for Medium-level Kidney Function volunteers

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rockefeller University	New York	New York	United States	10065

Sponsors and Collaborators

• Rockefeller University

Investigators

• Principal Investigator: Manish Ponda, MD, Rockefeller University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manish Ponda, Assistant Professor of Clinical Investigation, Rockefeller University
• ClinicalTrials.gov Identifier: NCT00772772
• Other Study ID Numbers: MAP-0626
• First Posted: Oct 15, 2008
• Last Update Posted: Jan 15, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Manish Ponda, Assistant Professor of Clinical Investigation, Rockefeller University: Vitamin D3 repletion; levels of endotoxin; intestinal permeability; accelerated atherosclerosis
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins

Study Results

Participant Flow

Arm/Group Title	Vitamin D3
Arm/Group Description	Vitamin D3 30,000 units PO weekly for 8 weeks
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Vitamin D3
Arm/Group Description
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (7)
Sex: Female, Male (Count of Participants)
Female	6 50%
Male	6 50%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Change in Endotoxin Activity
Description	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).
Time Frame	baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

Per protocol. Result is expressed as change in endotoxin activity with therapy

Arm/Group Title	Patients With Chronic Kidney Disease (CKD)
Arm/Group Description	CKD patients who were Vitamin D deficient and received Vitamin D3 repletion
Measure Participants	12
Mean (Standard Deviation) [EA units]	-.057 (.018)

2. Secondary Outcome

Title	Blood Pressure
Time Frame	after 8 weeks of vitamin D therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Intestinal Permeability
Time Frame	after 8 weeks of vitamin D therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Nuclear Magnetic Resonance (NMR) Lipoprotein Profile
Time Frame	after 8 weeks of vitamin D therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	25-hydroxy Vitamin D (25-OH Vitamin D)
Description	25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly.
Time Frame	after 8 weeks of vitamin D therapy

Outcome Measure Data

Analysis Population Description

Patients with chronic kidney disease had 25-OH vitamin D levels measured at baseline and after 8 weeks of Vitamin D3 therapy. Analysis was per protocol.

Arm/Group Title	CKD Patients
Arm/Group Description
Measure Participants	12
Mean (Standard Error) [ng/ml]	37.4 (3.0)

6. Secondary Outcome

Title	1, 25-OH Vitamin D
Time Frame	after 8 weeks of vitamin D therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Vitamin D3
Arm/Group Description
All Cause Mortality
	Vitamin D3
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Vitamin D3
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Vitamin D3
	Affected / at Risk (%)	# Events
Total	4/12 (33.3%)
Blood and lymphatic system disorders
Hematologic	1/1 (100%)	1
Cardiac disorders
Cardiovascular	1/1 (100%)	1
Metabolism and nutrition disorders
Metabolic	2/2 (100%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.