Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp

September 27, 2023 updated by: University of Nebraska

This is a randomized, controlled, unblinded pilot study for patients with vitamin D deficiency in Intestinal Rehabilitation clinic. These patients are not able to absorb oral vitamin D efficiently and thus have a high prevalence of vitamin D deficiency, leading to low bone density.

The investigators will use FDA approved portable Ultraviolet B lamp for the intervention group, 11 patients will be recruited from October 2013 to end of January 2014 and study period is 12 weeks for each patient. Study completion will be end of April 2014.

Study hypothesis: Ultraviolet B light with a portable ultraviolet device will increase Total 25 hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vitamin D plays an integral role in bone metabolism and is one of the principal hormonal regulators of calcium and phosphorus absorption in the body. In 2011, the Endocrine Society defined Vitamin D deficiency as a 25 hydroxy vitamin D below 20 ng/ml and vitamin D insufficiency as a 25 hydroxy vitamin D of 21 ng/ml to 29 ng/ml.Without vitamin D, only 10 to 15% of dietary calcium and about 60% of phosphorus is absorbed.

Intestinal Rehabilitation clinic at University of Nebraska Medical Center includes patients with short bowel syndrome, multiple abdominal fistulae, and altered GI motility.

Hypovitaminosis D is associated with increased parathyroid hormone secretion,increased bone turnover, osteoporosis, histological osteomalacia and increased risk of hip and other fractures, and, in its most severe expression,clinical osteomalacia. These patients have been given high doses of both oral vitamin D2 and vitamin D3 supplementation without an improvement in vitamin D status due to poor intestinal absorption . Standardized treatment of vitamin D deficiency in most healthy individuals is achieved by giving vitamin D2 50,000 IU once a week for few weeks and then daily supplementation with lower doses. In the investigators Intestinal rehabilitation clinic, these patients are vitamin D insufficient or deficient while on large replacement doses of vitamin D2/D3 with some taking 200,000 IU daily.

It has been reported that irradiation with Ultraviolet B can be used safely and effectively to treat vitamin D deficiency among vitamin D deficient patients. Exposure of the body in a bathing suit to 1 Minimum Erythemal Dose (MED) of sunlight is equivalent to ingesting about 10,000 IU to 25,000 IU of vitamin D. Thus, exposure of 6% to 10% of the body surface to 1 MED is equivalent to ingesting about 600 to 2500 IU of vitamin D. Although ultraviolet irradiation can be achieved from exposure to sunlight, it is generally available only seasonally and difficult for persons who are too ill to spend much time outdoors. Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky,USA) was designed to use ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.

Baseline labs include 25 hydroxy D, intact parathyroid hormone and complete metabolic profile. Patients will receive a 3 minute skin exposure to Ultraviolet B light and if they do not develop a sun burn, they will be randomized to Control or Ultraviolet B light group. Patients will continue their current dose of Vitamin D2/D3 for 12 weeks in both groups.Ultraviolet B light will be administered in 3 different areas on the same day for 5 minutes each, once a week at a distance of 14 inches wearing an UV eye shield. Areas of skin exposure will be based on rule of nine for body surface area which includes back, abdomen, thighs, and arms.

Patients will get blood draws at baseline and 12 weeks to monitor response to Ultraviolet B light. If Ultraviolet B light is able to increase total 25 hydroxy vitamin D level, it can potentially be used at home by these patients after receiving basic training and instructions.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 25-hydroxy vitamin D level between 15ng/ml to 30mg/ml
  • Age 19 years and above
  • Patients on a stable dose of vitamin D2/D3 for last 3 months

Exclusion Criteria:

  • Hypercalcemia (Serum Calcium (calculated) more than 1 mg/dl above the upper limit of normal i.e 11.3 mg/dl)
  • Symptomatic Hypocalcemia (described as tetany )
  • History of Sarcoidosis or Granulomatous diseases
  • Patients on Calcitriol
  • Liver failure defined as bilirubin more than 3, International Normalized Ratio of more than 3, Hepatic Transaminases 3 times of upper limit of normal, Decompensated cirrhosis with signs or icterus, varices, portal hypertension, encephalopathy.
  • History of transplant or undergoing transplant evaluation
  • Planned or Elective surgery in 6 months
  • Personal or Family history of skin cancer
  • History of photosensitivity
  • Active skin disease in the areas planned for Ultraviolet B exposure
  • Medications that limit sunlight exposure (such as tetracyclines or fluoroquinolones)
  • Patients already undergoing tanning sessions
  • Patients who are planning pregnancy or are breastfeeding
  • Subjects with fair skin type I (Always burns easily, never tans)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultraviolet B lamp
Intervention arm: Patients in the Ultraviolet B lamp group will continue vitamin D2/D3 daily and will receive 3 treatment sessions of Ultraviolet B light once a week for 12 weeks. Patients will receive Ultraviolet B light from Ultraviolet B lamp at a distance of 14 inches for duration of 5 minutes each area while wearing an Ultraviolet eye shield. Areas of skin exposure will include 3 different areas amounting to 27% of body surface area. 9% body surface area will include front of abdomen, lower back, each arm, each leg is 18%, each thigh. Ultraviolet B light sessions will be supervised and conducted by study personnel or Center for Clinical and Translational Research staff. A food questionnaire will be reviewed at each visit to assess dietary intake of calcium. Skin exam will be conducted at the beginning and end of the session.
Device: Ultraviolet B lamp
Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky, USA) was designed to use Ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.
Other Names:
  • Sperti sunlamp "Del Sol"; Sperti, Crescent Springs, Kentucky
No Intervention: Control
Patients in control group will continue with their current dose of Vitamin D2/D3 for 12 weeks.Patients will remain on the same steady dose for the duration of the study.These patients will not receive Ultraviolet B light sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
25 Hydroxy Vitamin D Levels
Time Frame: 12 weeks

Our hypothesis is that Ultraviolet B light with a portable Ultraviolet device will increase Total 25 hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients.

We will measure serum level of 25 hydroxy vitamin D at baseline and 12 weeks to monitor the response of Ultraviolet B exposure administered by the portable Ultraviolet B lamp.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Intact Parathyroid Hormone Level
Time Frame: 12 weeks
Hypovitaminosis D is associated with increased Parathyroid hormone secretion (inversely related to 25 hydroxy D), increased bone turnover, osteoporosis, histological osteomalacia and increased risk of hip and other fractures, and, in its most severe expression,clinical osteomalacia.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Lynn R Mack, MD, University of Nebraska Medical Center, Omaha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 23, 2013

First Posted (Estimated)

August 29, 2013

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0395-13-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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