NCT02676674

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

February 3, 2016

Last Update Submit

October 30, 2019

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Change in vitamin D

    Two sample paired t test of pre and post total serum 25-OH vitamin D level

    4 weeks

Secondary Outcomes (3)

  • Parathyroid hormone level

    4 weeks

  • Calcium level

    4 weeks

  • Skin irritation

    4 weeks

Study Arms (2)

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.

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.

Drug: Dose 2

Interventions

Dose 1DRUG

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.

Also known as: cholecalciferol, 25-OH Vitamin D
Dose 1
Dose 2DRUG

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.

Also known as: cholecalciferol
Dose 2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Physicians - Phalen Village Clinic

Saint Paul, Minnesota, 55106, United States

Location

Related Publications (2)

  • 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.

    PMID: 19307527BACKGROUND

  • 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.

    PMID: 12034416BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Kevin A Peterson, MD, MPH

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 8, 2016

Study Start

March 1, 2016

Primary Completion

June 15, 2017

Study Completion

June 15, 2017

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)