Vitamin D InadequacyD2/D3NCT00692120
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
A study testing Cholecalciferol (vitamin D3) and Ergocalciferol (vitamin D2) in people with Vitamin D Inadequacy and Vitamin D Deficiency, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Inadequacy, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol (vitamin D3) and Ergocalciferol (vitamin D2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Osteoporosis Clinical and Research Program
Madison, Wisconsin, 53705
About this study
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.
- Conditions
- Vitamin D Inadequacy, Vitamin D Deficiency
- Being tested
- Cholecalciferol (vitamin D3), Ergocalciferol (vitamin D2), Placebo
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol (vitamin D3)Dietary supplement
50,000 IU once monthly for 12 months
Ergocalciferol (vitamin D2)Dietary supplement
oral capsule 50,000 IU once monthly for 12 months
Ergocalciferol (vitamin D2)Dietary supplement
oral capsule 1600 IU once daily for 12 months
Cholecalciferol (vitamin D3)Dietary supplement
oral capsule 1600 IU once daily for 12 months
PlaceboDietary supplement
oral placebo capsule once daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Ergocalciferol (vitamin D2); Dietary Supplement: Placebo |
| 2 | Experimental | Not described Receives: Dietary Supplement: Ergocalciferol (vitamin D2); Dietary Supplement: Placebo |
| 3 | Experimental | Not described Receives: Dietary Supplement: Cholecalciferol (vitamin D3); Dietary Supplement: Placebo |
| 4 | Experimental | Not described Receives: Dietary Supplement: Cholecalciferol (vitamin D3); Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens.
Measured: 12 months
Secondary outcomes (2)
Determine whether once monthly vitamin D2 or D3 dosing is as effective as daily dosing in attainment, and subsequent maintenance, of 25OHD status
Measured: 12 months
Delineate the effect of these vitamin D regimens on other parameters of skeletal relevance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startFeb 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D InadequacyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Binkley, MD, Principal investigator, University of Wisconsin - Institute on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692120
- Sponsor's protocol ID
- 2006-0013
- Acronym
- D2/D3
- Status last verified
- Apr 2010
- First submitted
- 2 Jan 2008
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21289249
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
- ClinicalTrials.gov ID
- NCT00692120
- Acronym / sponsor ID
- D2/D3 / 2006-0013
- Conditions
- Vitamin D Inadequacy, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Ergocalciferol (vitamin D2), Dietary Supplement: Placebo |
| 2 | Experimental | Dietary Supplement: Ergocalciferol (vitamin D2), Dietary Supplement: Placebo |
| 3 | Experimental | Dietary Supplement: Cholecalciferol (vitamin D3), Dietary Supplement: Placebo |
| 4 | Experimental | Dietary Supplement: Cholecalciferol (vitamin D3), Dietary Supplement: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferol (vitamin D3)50,000 IU once monthly for 12 months | Dietary supplement | 3 |
| Ergocalciferol (vitamin D2)oral capsule 50,000 IU once monthly for 12 months | Dietary supplement | 1 |
| Ergocalciferol (vitamin D2)oral capsule 1600 IU once daily for 12 months | Dietary supplement | 2 |
| Cholecalciferol (vitamin D3)oral capsule 1600 IU once daily for 12 months | Dietary supplement | 4 |
| Placebooral placebo capsule once daily for 12 months | Dietary supplement | 1, 2, 3, 4 |
Primary outcome
The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens.
Time frame: 12 months
2 secondary outcomes
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
Delineate the effect of these vitamin D regimens on other parameters of skeletal relevance
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Derived from this study: PubMed 21289249Binkley 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Binkley, MD principal investigator
University of Wisconsin - Institute on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol (vitamin D3) and Ergocalciferol (vitamin D2) in people with Vitamin D Inadequacy and Vitamin D Deficiency, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.