Vitamin D Repletion in Chronic Kidney Disease

The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00772772

Enrollment

Registered

2008-10-15

Start date

2008-03-31

Completion date

2009-10-31

Last updated

2015-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

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

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.

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.

Interventions

DRUGVitamin 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	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.
1, 25-OH Vitamin D	after 8 weeks of vitamin D therapy	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Vitamin D3	12
Total	12

Baseline characteristics

Characteristic	Vitamin D3
Age, Continuous	61 years STANDARD_DEVIATION 7
Region of Enrollment United States	12 participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	4 / 12
serious Total, serious adverse events	0 / 12

Outcome results

Primary

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).

Time frame: baseline and 8 weeks

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

Arm	Measure	Value (MEAN)	Dispersion
Patients With Chronic Kidney Disease (CKD)	Change in Endotoxin Activity	-.057 EA units	Standard Deviation 0.018

Secondary