Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects

• ClinicalTrials.gov Identifier: NCT00427037
• Recruitment Status: Completed
• First Posted: January 26, 2007
• Results First Posted: March 12, 2009
• Last Update Posted: July 22, 2015
• Sponsor: Atlanta VA Medical Center
• Information provided by (Responsible Party): Vin Tangpricha, Atlanta VA Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Conditions: Chronic Kidney Disease; Vitamin D Deficiency
• Interventions: Drug: Cholecalciferol; Drug: Placebo
• Enrollment: 34

Participant Flow

Recruitment Details	Study subjects were recruited from Nephrology and Endocrinology clinics at Emory University School of Medicine
Pre-assignment Details

Arm/Group Title	Placebo	Cholecalciferol
Arm/Group Description	This is a matching placebo	This is vitamin D3 or Cholecalciferol
Period Title: Overall Study
Started	17	17
Completed	10	10
Not Completed	7	7

Baseline Characteristics

Arm/Group Title		Placebo	Cholecalciferol	Total
Arm/Group Description		This is a matching placebo	This is vitamin D3 or Cholecalciferol	Total of all reporting groups
Overall Number of Baseline Participants		17	17	34
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants	17 participants	34 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	14 82.4%	14 82.4%	28 82.4%
	>=65 years	3 17.6%	3 17.6%	6 17.6%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	17 participants	17 participants	34 participants
		59.5 (10.4)	62.2 (11)	60.8 (11)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants	17 participants	34 participants
	Female	7 41.2%	7 41.2%	14 41.2%
	Male	10 58.8%	10 58.8%	20 58.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	17 participants	17 participants	34 participants
		17	17	34

Outcome Measures

1. Primary Outcome

Title	25-hydroxyvitamin D
Description	25-hydroxyvitamin D measured in serum by ELISA
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Cholecalciferol
Arm/Group Description:	This is a matching placebo	This is vitamin D3 or Cholecalciferol
Overall Number of Participants Analyzed	10	10
Mean (95% Confidence Interval); Unit of Measure: ng/mL
Baseline	18.6; (12.8 to 27.1)	17.3; (11.8 to 25.2)
12 weeks	19.5; (13.4 to 28.4)	49.4; (33.9 to 72)

2. Secondary Outcome

Title	Bone Turnover Marker-CTX
Description	Blood levels of C-telopeptide
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Cholecalciferol
Arm/Group Description:	Placebo Placebo: identical placebo pill orally by mouth	D3 Cholecalciferol: 50,000 IU weekly by mouth
Overall Number of Participants Analyzed	8	9
Geometric Mean (95% Confidence Interval); Unit of Measure: pg/mL
	0.24; (0.14 to 0.4)	0.29; (0.18 to 0.49)

Adverse Events

Time Frame	3 Months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo		Cholecalciferol
Arm/Group Description	This is a matching placebo		This is vitamin D3 or Cholecalciferol
All-Cause Mortality
	Placebo		Cholecalciferol
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Placebo		Cholecalciferol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/17 (5.88%)		1/17 (5.88%)
General disorders
Death †	1/17 (5.88%)	1	1/17 (5.88%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo		Cholecalciferol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0.00%)		0/17 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

Results Point of Contact

• Name/Title: Vin Tangpricha
• Organization: Emory University School of Medicine
• Phone: 404-727-7254
• EMail: vin.tangpricha@emory.edu

Publications of Results:

Chandra P, Binongo JN, Ziegler TR, Schlanger LE, Wang W, Someren JT, Tangpricha V. Cholecalciferol (vitamin D3) therapy and vitamin D insufficiency in patients with chronic kidney disease: a randomized controlled pilot study. Endocr Pract. 2008 Jan-Feb;14(1):10-7. doi: 10.4158/EP.14.1.10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Alvarez JA, Law J, Coakley KE, Zughaier SM, Hao L, Shahid Salles K, Wasse H, Gutierrez OM, Ziegler TR, Tangpricha V. High-dose cholecalciferol reduces parathyroid hormone in patients with early chronic kidney disease: a pilot, randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2012 Sep;96(3):672-9. doi: 10.3945/ajcn.112.040642. Epub 2012 Aug 1.

• Responsible Party: Vin Tangpricha, Atlanta VA Medical Center
• ClinicalTrials.gov Identifier: NCT00427037
• Other Study ID Numbers: Vitamin D-2006
• First Submitted: January 24, 2007
• First Posted: January 26, 2007
• Results First Submitted: January 14, 2009
• Results First Posted: March 12, 2009
• Last Update Posted: July 22, 2015