UPGRADE: Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01173848
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 15.6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney disease who are not on dialysis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Stage 3 and 4	Drug: Ergocalciferol; Drug: Cholecalciferol	Phase 3

Detailed Description

Subjects will be randomized and assigned to one of the treatment groups (D2 or D3). Subjects will be dispensed a supply of 1.25 mg cholecalciferol/ergocalciferol tablets, depending on their randomization outcome. The number of pills dispensed and medication instructions will be determined by their 25OHD level and K/DOQI guidelines. Both Study personnel and subject will be blinded to randomization group.

The treatment phase will be 24 weeks in duration with lab visits every 6 weeks. All laboratory specimens will be drawn either at CCF Main hospital labs or at a CCF family Health center lab. Subjects will be have telephone interviews at week 4, 10, 16, 22 and possibly at weeks 28 and 34.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Study to Evaluate the Effectiveness of Cholecalciferol Versus Ergocalciferol Following Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines for Vitamin D Therapy in Stages 3 & 4 Chronic Kidney Disease (CKD) Patients
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Oct 18, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vitamin D2 Patients randomized to take vitamin D2	Drug: Ergocalciferol; 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months
Active Comparator: Vitamin D3 Patient's randomized to take Vitamin D3	Drug: Cholecalciferol; 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months

Outcome Measures

Primary Outcome Measures

1. Subjects Achieving Normal Vitamin D Levels [within 24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults ≥ 18 years

• Chronic kidney disease stage 3-4 (eGFR 15-59 mL/min/1.73m2 body surface area, calculated using the MDRD Study equation GFR calculator)

• Hypovitaminosis D (serum 25OHD < 31 ng/mL)

• Secondary hyperparathyroidism (Intact PTH > 70 pg/mL for stage 3, and iPTH > 110 pg/mL for stage 4)

Exclusion Criteria:

• Initiation of vitamin D therapy between the time of the lab draw used for screening and the screening process

• History of liver failure

• History of intestinal malabsorption or chronic diarrhea

• Serum calcium level greater than 10.2 mg/dL

• Treatment with an activated vitamin D formulation (calcitriol, doxercalciferol or paricalcitol) within the past 6 months

• Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism

• Primary hyperparathyroidism, active of a prior history of such

• Active malignancy excluding basal cell or localized squamous cell skin cancer

• Subject is pregnant (e.g. positive HCG test) or breast-feeding

• Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the treatment phase of the study

• Serum phosphorus level greater than 4.5 or treatment with an oral phosphate binder within the past 6 months

• Treatment with cinacalcet or other calcimimetic within the past 6 months

• Anticipated dialysis within 6 months after randomization

• Inability to swallow tablets

• Known sensitivity, intolerance, or other adverse response to the study drugs which would prevent compliance with study medication

• Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator

• Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).

• Current treatment with vitamin D 50,000 IU

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: James F Simon, M.D., The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01173848
• Other Study ID Numbers: Cleveland Clinic
• First Posted: Aug 2, 2010
• Last Update Posted: Apr 4, 2017
• Last Verified: Jul 1, 2013

• Keywords provided by The Cleveland Clinic: CKD; Vitamin D
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Cholecalciferol; Vitamin D; Ergocalciferols

Study Results

Participant Flow

Arm/Group Title	Vitamin D2	Vitamin D3
Arm/Group Description	Patients randomized to take vitamin D2 Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months	Patient's randomized to take Vitamin D3 Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months
Period Title: Overall Study
STARTED	8	11
COMPLETED	4	3
NOT COMPLETED	4	8

Baseline Characteristics

Arm/Group Title	Vitamin D2	Vitamin D3	Total
Arm/Group Description	Patients randomized to take vitamin D2 Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months	Patient's randomized to take Vitamin D3 Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months	Total of all reporting groups
Overall Participants	8	11	19
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 37.5%	3 27.3%	6 31.6%
>=65 years	5 62.5%	8 72.7%	13 68.4%
Sex: Female, Male (Count of Participants)
Female	2 25%	6 54.5%	8 42.1%
Male	6 75%	5 45.5%	11 57.9%

Outcome Measures

1. Primary Outcome

Title	Subjects Achieving Normal Vitamin D Levels
Time Frame	within 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vitamin D2	Vitamin D3
Arm/Group Description	Patients randomized to take vitamin D2 Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months	Patient's randomized to take Vitamin D3 Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months
Measure Participants	8	9
Number [participants]	4 50%	4 36.4%

Adverse Events

Arm/Group Title	Vitamin D2 and Vitamin D3
Arm/Group Description	Adverse Events were not logged by study arms. Patients randomized to take vitamin D2 Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months or Patient's randomized to take Vitamin D3 Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months
All Cause Mortality
	Vitamin D2 and Vitamin D3
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Serious Adverse Events
	Vitamin D2 and Vitamin D3
	Affected / at Risk (%)	# Events
Total	7/19 (36.8%)
Cardiac disorders
Atrial Fibrillation	1/19 (5.3%)
Endocrine disorders
Urinary Tract Infection	1/19 (5.3%)
Acute Renal Failure	1/19 (5.3%)
Infections and infestations
Pneumonia	1/19 (5.3%)
Hospitalization	1/19 (5.3%)
Metabolism and nutrition disorders
Hospitalization for Dehydration	1/19 (5.3%)
Musculoskeletal and connective tissue disorders
Left Side Back Pain	1/19 (5.3%)
Other (Not Including Serious) Adverse Events
	Vitamin D2 and Vitamin D3
	Affected / at Risk (%)	# Events
Total	18/19 (94.7%)
Gastrointestinal disorders
Constipation	3/19 (15.8%)
Loose Stools	1/19 (5.3%)
General disorders
Nails Cracking and Falling Off	1/19 (5.3%)
Cystic Fibrosis	1/19 (5.3%)
Dizziness	1/19 (5.3%)
Worsening Hyperglycemia	1/19 (5.3%)
Hematuria	1/19 (5.3%)
Stomach Cramping	1/19 (5.3%)
Allergies	1/19 (5.3%)
Leg Cramps	1/19 (5.3%)
Fatigue	1/19 (5.3%)
Acid Reflux	1/19 (5.3%)
Metabolism and nutrition disorders
High Potassium	1/19 (5.3%)
Renal and urinary disorders
Cloudy Urine	1/19 (5.3%)
Urinary Tract Infection	1/19 (5.3%)
Respiratory, thoracic and mediastinal disorders
Bronchitis	1/19 (5.3%)

Limitations/Caveats

Adverse Events were not logged by study arms. Early termination of the study lead to small numbers of subjects analyzed.

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.