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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose 1 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vitamin D | Two sample paired t test of pre and post total serum 25-OH vitamin D level | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Parathyroid hormone level | Two sample paired t test of pre and post total vitamin D level | 4 weeks |
| Calcium level | Identification of any potential albumen adjusted hypercalcemia events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin A Peterson, MD, MPH | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Physicians - Phalen Village Clinic | Saint Paul | Minnesota | 55106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19307527 | Background | 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. | |
| 12034416 | Background | Tangpricha 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 16, 2016 | Nov 15, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 16, 2016 | Nov 15, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Dose 2 | Drug | 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. |
|
|
| 4 weeks |
| Skin irritation | Identification of any skin irritation events | 4 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |