Impact of Vitamin D Therapies on Chronic Kidney Disease

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01222234
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 3
• Duration (Months): 22
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease (CKD); End-stage Renal Disease (ESRD)	Drug: Cholecalciferol - CKD; Device: Calcitriol - CKD; Drug: Cholecalciferol - non-CKD	N/A

Detailed Description

Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle.

Vitamin D is useful in people with all different types of health issues. CKD is the slow loss of kidney function over time. The main function of the kidneys is to remove wastes and excess water from the body. This loss of function usually takes months or years to occur Patients with CKD often have low levels of vitamin D in their blood.

This study will have two groups of patients with CKD and one group of patients that have normal kidney function, but all groups will have low levels of vitamin D. The two groups with CKD (group 1 and group 2) will receive either cholecalciferol or calcitriol. The purpose of having a control group (group 3) without CKD will be to evaluate if any changes that are witnessed in response to vitamin D therapy are specific to patients with kidney disease or apply to all patients with vitamin D deficiency who receive vitamin D supplements.

There are two different drugs in this study. One is called Calcitriol and is approved by the Food and Drug Administration (FDA) as a vitamin D supplement. The other drug is called cholecalciferol and it is approved by the FDA. Unlike calcitriol, cholecalciferol is a nutritional form of vitamin D that can often be found in various types of foods and its chemical structure must be changed by the body to become the active form of vitamin D. It is believed that cholecalciferol may have different effects in the body compared to calcitriol. It is possible that CKD patients would benefit from receiving both of these drugs, but this is currently unclear. While on this study you will receive either one of these study drugs, depending on which group you are assigned to.

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Vitamin D Therapies on Monocyte Function in Chronic Kidney Disease
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Cholecalciferol - CKD Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks.	Drug: Cholecalciferol - CKD; Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks; Other Names: Vitamin D3
Experimental: Group 2: Calcitriol - CKD Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered calcitriol 0.25mcg daily for 8 weeks.	Device: Calcitriol - CKD; Calcitriol 0.25 mcg once daily for 8 weeks; Other Names: 1,25(OH)2D
Experimental: Group 3: Cholecalciferol - non-CKD Patients in this arm have low vitamin D levels and normal kidney function. They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks.	Drug: Cholecalciferol - non-CKD; Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks; Other Names: Vitamin D3

Outcome Measures

Primary Outcome Measures

1. Monocyte Protein Expression [8 weeks of therapy]

   Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression

2. Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol [8 weeks of therapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic kidney disease w/GFR<35ml/min

• Nutritional vitamin D deficiency, defined as 25(OH)D < 25ng/ml

• Secondary hyperparathyroidism, PTH>75pg/mL

Exclusion Criteria:

• Active infection

• Recent hospitalization for acute illness (within last month)

• Refusal to study participation

• History of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, SLE, etc.)

• Allergy to cholecalciferol or calcitriol

• History of parathyroidectomy

• Functional renal transplant within 5 years

• Current treatment with immunosuppressant medications

• Noncompliance with prescribed medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center

Investigators

• Principal Investigator: Jason Stubbs, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jason Stubbs, MD, Assistant Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT01222234
• Other Study ID Numbers: 11936
• First Posted: Oct 18, 2010
• Last Update Posted: May 16, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Vitamin D; Ergocalciferols; Cholecalciferol; Calcitriol; Vitamins

Study Results

Participant Flow

Arm/Group Title	Group 1: Cholecalciferol	Group 2: Calcitriol	Group 3: Cholecalciferol
Arm/Group Description	Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2. Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week	Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2. calcitriol: calcitriol 0.25 mcg every day	Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3. Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week
Period Title: Overall Study
STARTED	15	17	24
COMPLETED	15	15	22
NOT COMPLETED	0	2	2

Baseline Characteristics

Arm/Group Title	Group 1: Cholecalciferol	Group 2: Calcitriol	Group 3: Cholecalciferol	Total
Arm/Group Description	Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2. Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week	Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2. calcitriol: calcitriol 0.25 mcg every day	Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3. Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week	Total of all reporting groups
Overall Participants	15	17	24	56
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	9 60%	11 64.7%	20 83.3%	40 71.4%
>=65 years	6 40%	6 35.3%	4 16.7%	16 28.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.1 (13.3)	59.8 (11.6)	48.5 (14.2)	56.1 (13.0)
Sex: Female, Male (Count of Participants)
Female	9 60%	10 58.8%	21 87.5%	40 71.4%
Male	6 40%	7 41.2%	3 12.5%	16 28.6%
Region of Enrollment (participants) [Number]
United States	15 100%	17 100%	24 100%	56 100%

Outcome Measures

1. Primary Outcome

Title	Monocyte Protein Expression
Description	Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression
Time Frame	8 weeks of therapy

Outcome Measure Data

Analysis Population Description

The primary comparison for this outcome was between only CKD groups (groups 1 and 2); therefore data from the non-CKD group (group 3) was not analyzed for this outcome. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.

Arm/Group Title	Group 1: Cholecalciferol - CKD	Group 2: Calcitriol - CKD
Arm/Group Description	Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2. Cholecalciferol 50,000 IU twice weekly for 8 weeks	Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2. Calcitriol 0.25 mcg every day
Measure Participants	15	15
CD14	34110 (9372)	38540 (16880)
ACE	1359 (347.2)	1360 (290.8)
VDR	2799 (1210)	3468 (3123)
Mac-1	14318 (4196.4)	14278.5 (4891.3)

2. Primary Outcome

Title	Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol
Time Frame	8 weeks of therapy

Outcome Measure Data

Analysis Population Description

The primary comparison for this outcome of interest was between subjects taking cholecalciferol, so the calcitriol group (group 2) was excluded from the analysis. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.

Arm/Group Title	Group 1: CKD Cholecalciferol	Group 3: Non-CKD Cholecalciferol
Arm/Group Description	Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2. Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week	Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3. Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week
Measure Participants	15	15
Mean (Standard Deviation) [ng/ml]	1.59 (0.73)	3.59 (1.14)

Adverse Events

Arm/Group Title	Group 1: Cholecalciferol		Group 2: Calcitriol		Group 3: Cholecalciferol
Arm/Group Description	Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2. Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week		Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2. calcitriol: calcitriol 0.25 mcg every day		Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3. Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week
All Cause Mortality
	Group 1: Cholecalciferol		Group 2: Calcitriol		Group 3: Cholecalciferol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1: Cholecalciferol		Group 2: Calcitriol		Group 3: Cholecalciferol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/17 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: Cholecalciferol		Group 2: Calcitriol		Group 3: Cholecalciferol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		1/17 (5.9%)		1/24 (4.2%)
Gastrointestinal disorders
constipation	0/15 (0%)	0	1/17 (5.9%)	1	0/24 (0%)	0
diarrhea	0/15 (0%)	0	0/17 (0%)	0	1/24 (4.2%)	1

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.