Vitamin D DeficiencyPhase 1NCT04120064
Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol
A Phase 1 study testing Cholecalciferol in people with Vitamin D Deficiency, run by Parkview Medical Center at 1 site in United States.
Trial summary
Comparing two treatment regimens (solitary large dose vs daily smaller dose) in patients diagnosed with vitamin D deficiency. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 15 Jan 2021
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75yrs old
- serum 25(OH)-vitamin D level <20ng/mL
- patient of Parkview Adult Medicine clinic
- not currently on cholecalciferol >2,000IU daily
- no ergocalciferol administration within last week
Who cannot join
- history of hypercalcemia or hyperparathyroidism
- history of chronic kidney disease with baseline creatinine >1.1
- history of gastric absorption abnormalities
- history of Paget's disease or osteomalacia
- history of thyrotoxicosis
- known malignancy
Show all 10Show fewer
- currently pregnant
- taking medications for osteoporosis or seizures
- taking more than 1200mg/day of calcium
- inpatient hospitalization at the initiation of study meds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol in the Outpatient Setting
Comparing two treatment regimens (solitary large dose vs daily smaller dose) in patients diagnosed with vitamin D deficiency.
Read the detailed description
Study is looking at patients with diagnosed vitamin D deficiency (<20ng/mL). Participants are healthy adults between 18 and 75. No diagnosis of cancer, pregnancy, hypercalcemia, hyperparathyroidism, gastrointestinal absorption disorder, or chronic kidney disease and not taking medications for seizures or osteoporosis. Participants are randomized into two treatment groups: (1) 5,000IU cholecalciferol daily or (2) one-time 300,000 international units (IU) cholecalciferol. Vitamin D level, calcium level, and renal function are measure one week after initiating treatment and then at 3 months, 6 months, 9 months, and 12 months.
- Conditions
- Vitamin D Deficiency
- Being tested
- Cholecalciferol
- 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.
CholecalciferolDrug
Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol
| Study group | Role | What they receive |
|---|---|---|
| Large bolus | Experimental | Not described Receives: Drug: Cholecalciferol |
| Standard | Active comparator | Not described Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment of vitamin D deficiency over a one year time frame: normalization of vitamin D levels above 30ng/mL
Looking for normalization of vitamin D levels
Measured: 12months
Secondary outcomes (2)
Duration of efficacy after starting vitamin D replacement as monitored at one week and then three month intervals for one year
Evaluation of how long participants maintain normal vitamin D levels with treatment
Measured: 1 week, 3 months, 6 months, 9 months, 12 months
Compliance with therapy as measured by the reported number of missed doses at one week on therapy and then every three months for a year
Evaluation of missed doses
Measured: 1 week, 3 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start25 Jan 2019
- Primary completion31 Dec 2020
- Study completion15 Jan 2021
Why it stopped: Covid19, not able to finish recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkview Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doug Duffee, Parkview Medical Center
- Investigators
- Stephanie Murphy, DO, Study chair, Parkview Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120064
- Sponsor's protocol ID
- PIRB64
- Status last verified
- Jan 2021
- First submitted
- 6 Sep 2019
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol in the Outpatient Setting
- ClinicalTrials.gov ID
- NCT04120064
- Acronym / sponsor ID
- PIRB64
- Conditions
- Vitamin D Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid19, not able to finish recruitment
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Parkview Medical CenterUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 9 Oct 2019 (actual)
- 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.
Comparing two treatment regimens (solitary large dose vs daily smaller dose) in patients diagnosed with vitamin D deficiency.
Detailed description
Study is looking at patients with diagnosed vitamin D deficiency (<20ng/mL). Participants are healthy adults between 18 and 75. No diagnosis of cancer, pregnancy, hypercalcemia, hyperparathyroidism, gastrointestinal absorption disorder, or chronic kidney disease and not taking medications for seizures or osteoporosis. Participants are randomized into two treatment groups: (1) 5,000IU cholecalciferol daily or (2) one-time 300,000 international units (IU) cholecalciferol. Vitamin D level, calcium level, and renal function are measure one week after initiating treatment and then at 3 months, 6 months, 9 months, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large bolus | Experimental | Drug: Cholecalciferol |
| Standard | Active comparator | Drug: Cholecalciferol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-75yrs old
- serum 25(OH)-vitamin D level <20ng/mL
- patient of Parkview Adult Medicine clinic
- not currently on cholecalciferol >2,000IU daily
- no ergocalciferol administration within last week
Key exclusion criteria (10 listed)
- history of hypercalcemia or hyperparathyroidism
- history of chronic kidney disease with baseline creatinine >1.1
- history of gastric absorption abnormalities
- history of Paget's disease or osteomalacia
- history of thyrotoxicosis
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 |
|---|---|---|
| CholecalciferolLarge, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol | Drug | Large bolus, Standard |
Primary outcome
Efficacy of treatment of vitamin D deficiency over a one year time frame: normalization of vitamin D levels above 30ng/mL
Time frame: 12months
Looking for normalization of vitamin D levels
2 secondary outcomes
Duration of efficacy after starting vitamin D replacement as monitored at one week and then three month intervals for one year
Time frame: 1 week, 3 months, 6 months, 9 months, 12 months
Compliance with therapy as measured by the reported number of missed doses at one week on therapy and then every three months for a year
Time frame: 1 week, 3 months, 6 months, 9 months, 12 months
Results and safety
The study was stopped early (reason given: Covid19, not able to finish recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Stephanie Murphy, DO study chair
Parkview Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cholecalciferol in people with Vitamin D Deficiency, run by Parkview Medical Center 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 1 Feb 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Covid19, not able to finish recruitment). Results are not available in the source record.
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?
Efficacy of treatment of vitamin D deficiency over a one year time frame: normalization of vitamin D levels above 30ng/mL (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2021.