Vitamin D DeficiencyPhase 1VITD-001NCT02676674
Vitamin D Levels Following Topical Application of Vitamin D Ointment
A Phase 1 study testing Dose 1 and Dose 2 in people with Vitamin D Deficiency, run by University of Minnesota at 1 site in United States.
Trial summary
This is a pre-post open label trial to assess the change in Vitamin D blood levels following treatment with three doses of topical Vitamin D3 in subjects with existing Vitamin D deficiency. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Dose 1 and Dose 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 15 Jun 2017
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Known vitamin D deficiency based on blood work obtained prior to study consent defined as serum 25-hydroxyvitamin D less than or equal to 20 ng/mL within 30 days prior to study entry.
- Adult, age 18 to 85 years, male or female
- If on oral vitamin D therapy, have been on a stable dose for the previous 90 days.
Who cannot join
- History of chronic liver disease with elevated liver function tests, chronic kidney disease (stage 3 or greater, eGFR <60 mL/min), uncontrolled thyroid disease (elevated thyroid function tests), primary or secondary hyperparathyroidism, hypercalcemia, or multiple endocrine neoplasia.
- Hypercalcemia defined as either elevated corrected serum calcium >10.2 mg/dL) measured within 3 months prior to study.
- estimated glomerular filtration rate (eGFR) <60 mL/min within 3 months prior to study.
- Active cancers
- Women who are pregnant or breastfeeding.
- Individuals who are unable to give informed consent
Show all 9Show fewer
- Individuals with psoriasis, active eczema or other skin disease, or who are currently receiving treatments or medications for skin disease.
- Individuals who do not agree to refrain from using tanning beds for the duration of the study.
- Individuals who do not agree to avoid submerging the ointment site in water for 8 hours after ointment application.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Physicians - Phalen Village Clinic
Saint Paul, Minnesota, 55106
About this study
Official title: Vitamin D Levels in Subjects With Vitamin D Deficiency Following Topical Application of Three Doses of Vitamin D Ointment - A Proof of Concept Study
This is a pre-post open label trial to assess the change in Vitamin D blood levels following treatment with three doses of topical Vitamin D3 in subjects with existing Vitamin D deficiency.
Read the detailed description
The proposed study investigates safety and efficacy of a new topical vitamin D3 compound. The purpose of this Phase 1 trial is to determine whether topical application makes Vitamin D bioavailable to the systemic circulation in sufficient quantities to treat hypovitaminosis D. The study will assess the change in serum 25-hydroxy (25-OH) vitamin D concentrations following 3 doses of 100,000 IU or 3 doses of 300,000 IU of topical vitamin D3 ointment in volunteers with vitamin D deficiency. Adults with serum 25-OH vitamin D concentrations of < 20 ng/ml will receive a total of 300,000 IU or 900,000 IU in divided doses of topical vitamin D once per week for three weeks. Two 0.75 ml applicators of ointment will be applied to each upper arm (50,000 IU or 150,000 IU per arm) by study staff. Blood will be drawn at baseline prior to the first dose (Day 0) and on Days 7, 14, and 21. Total serum 25-OH vitamin D will be assayed at each draw. Parathyroid hormone, a measure of clinical effects of low vitamin D levels, will be checked at baseline and on day 21. Serum albumin adjusted calcium levels will be checked with each draw to check for possible effects of too much vitamin D absorption. The study will determine whether the topical application of Vitamin D ointment is able to correct existing vitamin D deficiency.
- Conditions
- Vitamin D Deficiency
- Being tested
- Dose 1, Dose 2
- 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.
Dose 1Drug
Also called cholecalciferol, 25-OH Vitamin D
Subjects with vitamin D deficiency will be given 100,000 units of topical vitamin D on days 0,7, and 14. Vitamin D levels will be checked on days 7, 14, and 21.
Dose 2Drug
Also called cholecalciferol
Subjects with vitamin D deficiency will be given 300,000 units of topical vitamin D on days 0,7, and 14. Vitamin D levels will be checked on days 7, 14, and 21.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Three topical applications of 100,000 units for a total of 300,000 units of vitamin D3 in a newly formulated ointment will be applied to the upper arms over three weeks. Receives: Drug: Dose 1 |
| Dose 2 | Experimental | Three topical applications of 300,000 units for a total of 900,000 units of vitamin D3 in a newly formulated ointment will be applied to the upper arms over three weeks. Receives: Drug: Dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin D
Two sample paired t test of pre and post total serum 25-OH vitamin D level
Measured: 4 weeks
Secondary outcomes (3)
Parathyroid hormone level
Two sample paired t test of pre and post total vitamin D level
Measured: 4 weeks
Calcium level
Identification of any potential albumen adjusted hypercalcemia events
Measured: 4 weeks
Skin irritation
Identification of any skin irritation events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startMar 2016
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin A Peterson, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676674
- Sponsor's protocol ID
- 602M84081
- Acronym
- VITD-001
- Status last verified
- Oct 2019
- First submitted
- 3 Feb 2016
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ginde AA, Liu MC, Camargo CA Jr. Demographic differences and trends of vitamin D insufficiency in the US population, 1988-2004. Arch Intern Med. 2009 Mar 23;169(6):626-32. doi: 10.1001/archinternmed.2008.604.
PubMed 19307527Tangpricha V, Pearce EN, Chen TC, Holick MF. Vitamin D insufficiency among free-living healthy young adults. Am J Med. 2002 Jun 1;112(8):659-62. doi: 10.1016/s0002-9343(02)01091-4.
PubMed 12034416
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Levels in Subjects With Vitamin D Deficiency Following Topical Application of Three Doses of Vitamin D Ointment - A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT02676674
- Acronym / sponsor ID
- VITD-001 / 602M84081
- Conditions
- Vitamin D Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 8 Feb 2016 (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.
This is a pre-post open label trial to assess the change in Vitamin D blood levels following treatment with three doses of topical Vitamin D3 in subjects with existing Vitamin D deficiency.
Detailed description
The proposed study investigates safety and efficacy of a new topical vitamin D3 compound. The purpose of this Phase 1 trial is to determine whether topical application makes Vitamin D bioavailable to the systemic circulation in sufficient quantities to treat hypovitaminosis D. The study will assess the change in serum 25-hydroxy (25-OH) vitamin D concentrations following 3 doses of 100,000 IU or 3 doses of 300,000 IU of topical vitamin D3 ointment in volunteers with vitamin D deficiency. Adults with serum 25-OH vitamin D concentrations of < 20 ng/ml will receive a total of 300,000 IU or 900,000 IU in divided doses of topical vitamin D once per week for three weeks. Two 0.75 ml applicators of ointment will be applied to each upper arm (50,000 IU or 150,000 IU per arm) by study staff. Blood will be drawn at baseline prior to the first dose (Day 0) and on Days 7, 14, and 21. Total serum 25-OH vitamin D will be assayed at each draw. Parathyroid hormone, a measure of clinical effects of low vitamin D levels, will be checked at baseline and on day 21. Serum albumin adjusted calcium levels will be checked with each draw to check for possible effects of too much vitamin D absorption. The study will determine whether the topical application of Vitamin D ointment is able to correct existing vitamin D deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: Dose 1Three topical applications of 100,000 units for a total of 300,000 units of vitamin D3 in a newly formulated ointment will be applied to the upper arms over three weeks. |
| Dose 2 | Experimental | Drug: Dose 2Three topical applications of 300,000 units for a total of 900,000 units of vitamin D3 in a newly formulated ointment will be applied to the upper arms over three weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Known vitamin D deficiency based on blood work obtained prior to study consent defined as serum 25-hydroxyvitamin D less than or equal to 20 ng/mL within 30 days prior to study entry.
- Adult, age 18 to 85 years, male or female
- If on oral vitamin D therapy, have been on a stable dose for the previous 90 days.
Key exclusion criteria (9 listed)
- History of chronic liver disease with elevated liver function tests, chronic kidney disease (stage 3 or greater, eGFR <60 mL/min), uncontrolled thyroid disease (elevated thyroid function tests), primary or secondary hyperparathyroidism, hypercalcemia, or multiple endocrine neoplasia.
- Hypercalcemia defined as either elevated corrected serum calcium >10.2 mg/dL) measured within 3 months prior to study.
- estimated glomerular filtration rate (eGFR) <60 mL/min within 3 months prior to study.
- Active cancers
- Women who are pregnant or breastfeeding.
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 |
|---|---|---|
| Dose 1Also: cholecalciferol, 25-OH Vitamin DSubjects with vitamin D deficiency will be given 100,000 units of topical vitamin D on days 0,7, and 14. Vitamin D levels will be checked on days 7, 14, and 21. | Drug | Dose 1 |
| Dose 2Also: cholecalciferolSubjects with vitamin D deficiency will be given 300,000 units of topical vitamin D on days 0,7, and 14. Vitamin D levels will be checked on days 7, 14, and 21. | Drug | Dose 2 |
Primary outcome
Change in vitamin D
Time frame: 4 weeks
Two sample paired t test of pre and post total serum 25-OH vitamin D level
3 secondary outcomes
Parathyroid hormone level
Time frame: 4 weeks
Calcium level
Time frame: 4 weeks
Skin irritation
Time frame: 4 weeks
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 1 Nov 2019.
- Background: PubMed 19307527Ginde AA, Liu MC, Camargo CA Jr. Demographic differences and trends of vitamin D insufficiency in the US population, 1988-2004. Arch Intern Med. 2009 Mar 23;169(6):626-32. doi: 10.1001/archinternmed.2008.604.
- Background: PubMed 12034416Tangpricha V, Pearce EN, Chen TC, Holick MF. Vitamin D insufficiency among free-living healthy young adults. Am J Med. 2002 Jun 1;112(8):659-62. doi: 10.1016/s0002-9343(02)01091-4.
- Individual participant dataSharing planned: No
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
Kevin A Peterson, MD, MPH principal investigator
University of Minnesota
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 Dose 1 and Dose 2 in people with Vitamin D Deficiency, run by University of Minnesota 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 3 inclusion and 9 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 1 Nov 2019. 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 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?
Change in vitamin D (time frame: 4 weeks). 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 NCT02676674, which also lists 2 linked publications.
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 Nov 2019.