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Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy (D2/D3)

Primary Purpose

Vitamin D Inadequacy, Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cholecalciferol (vitamin D3)

Ergocalciferol (vitamin D2)

Cholecalciferol (vitamin D3)

Placebo

About this trial

This is an interventional treatment trial for Vitamin D Inadequacy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Community dwelling men and women age ≥ 65 years.
Able and willing to sign informed consent.
Serum 25OHD concentration ≥ 10 and less than 60 ng/ml by HPLC.
Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing ≤ 400 IU used no more than once daily will be allowed

Exclusion Criteria:

Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism.
History of nephrolithiasis.
Screening 25OHD concentration ≥ 60 ng/ml.
Baseline 24-hour urine calcium > 250 mg if female, > 300 mg if male.
Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease
History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin cancer.
Renal failure defined as a calculated creatinine clearance (Cockroft-Gault method) ≤ 25 ml/minute
Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which may limit ability to complete the study
Known malabsorption syndromes, e.g., celiac disease, radiation enteritis, active inflammatory bowel disease, etc.
Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, PTH, testosterone or calcitonin
Vitamin D intake greater than 5,000 IU daily
Treatment with any active metabolites of vitamin D within six months of screening
Treatment with any drug which may interfere with vitamin D metabolism, e.g., phenobarbital, phenytoin.

Sites / Locations

UW Osteoporosis Clinical and Research Program

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens.

Secondary Outcome Measures

Determine whether once monthly vitamin D2 or D3 dosing is as effective as daily dosing in attainment, and subsequent maintenance, of 25OHD status

Delineate the effect of these vitamin D regimens on other parameters of skeletal relevance

Full Information

NCT ID

NCT00692120

First Posted

January 2, 2008

Last Updated

October 1, 2015

Sponsor

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT00692120

Brief Title

Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy

Acronym

D2/D3

Official Title

Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been assumed that these two forms maintain blood vitamin D equally. However, this may not be the case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D. Additionally, it will evaluate whether once per month vitamin D dosing is as effective in maintaining blood vitamin D levels as daily dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Inadequacy, Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Cholecalciferol (vitamin D3)

Intervention Description

50,000 IU once monthly for 12 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Ergocalciferol (vitamin D2)

Intervention Description

oral capsule 50,000 IU once monthly for 12 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Ergocalciferol (vitamin D2)

Intervention Description

oral capsule 1600 IU once daily for 12 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Cholecalciferol (vitamin D3)

Intervention Description

oral capsule 1600 IU once daily for 12 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

oral placebo capsule once daily for 12 months

Primary Outcome Measure Information:

Title

The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Determine whether once monthly vitamin D2 or D3 dosing is as effective as daily dosing in attainment, and subsequent maintenance, of 25OHD status

Time Frame

12 months

Title

Delineate the effect of these vitamin D regimens on other parameters of skeletal relevance

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Community dwelling men and women age ≥ 65 years. Able and willing to sign informed consent. Serum 25OHD concentration ≥ 10 and less than 60 ng/ml by HPLC. Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing ≤ 400 IU used no more than once daily will be allowed Exclusion Criteria: Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism. History of nephrolithiasis. Screening 25OHD concentration ≥ 60 ng/ml. Baseline 24-hour urine calcium > 250 mg if female, > 300 mg if male. Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin cancer. Renal failure defined as a calculated creatinine clearance (Cockroft-Gault method) ≤ 25 ml/minute Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which may limit ability to complete the study Known malabsorption syndromes, e.g., celiac disease, radiation enteritis, active inflammatory bowel disease, etc. Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, PTH, testosterone or calcitonin Vitamin D intake greater than 5,000 IU daily Treatment with any active metabolites of vitamin D within six months of screening Treatment with any drug which may interfere with vitamin D metabolism, e.g., phenobarbital, phenytoin.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil Binkley, MD

Organizational Affiliation

University of Wisconsin - Institute on Aging

Official's Role

Principal Investigator

Facility Information:

Facility Name

UW Osteoporosis Clinical and Research Program

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21289249

Citation

Binkley N, Gemar D, Engelke J, Gangnon R, Ramamurthy R, Krueger D, Drezner MK. Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults. J Clin Endocrinol Metab. 2011 Apr;96(4):981-8. doi: 10.1210/jc.2010-0015. Epub 2011 Feb 2.

Results Reference

derived

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Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy

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