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Ultraviolet Light And Vitamin D In Subjects With Fat Malabsorption Or After Gastric Bypass Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01910792
First Posted: July 30, 2013
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael F. Holick, Boston University
  Purpose

Patients with fat malabsorption due to Crohn's disease, ulcerative colitis, or other causes including cystic fibrosis, among others, or who have undergone gastric bypass have increased incidence of vitamin D deficiency relative to the general population. Given that vitamin D is fat soluble and absorbed in the proximal small intestine, it has been documented that vitamin D deficiency in people with a fat malabsorption syndrome is due to decreased absorption of vitamin D.

The amount of vitamin D produced from winter sunlight (in Boston, MA) and dietary sources will negligibly raise blood vitamin D levels in these patients, and oral vitamin D supplementation may have limited efficacy due to malabsorption. A variety of UV light sources have been developed and sold as in-home tanning devices and to produce vitamin D in reptiles. The efficacy of correcting vitamin D deficiency by the skin exposure to an artificial source of UVB radiation in patients with fat malabsorption syndromes (Crohn's disease, ulcerative colitis, or cystic fibrosis) or after gastric bypass surgery has not been studied. The investigators have conducted a pilot study in healthy adults that demonstrated that exposure to the lamp raised the blood level of 25-hydroxyvitamin D with no side effects. The main purpose of this study is to evaluate the effect of the FDA approved artificial source of ultraviolet (UVB) radiation (Sperti® lamp) in improving vitamin D status in patients with fat malabsorption syndromes and patients who have undergone roux-en-Y gastric bypass surgery.


Condition Intervention
Vitamin D Deficiency Gastrointestinal Diseases Device: Sperti Lamp

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Ultraviolet Light and Vitamin D in Subjects With Fat Malabsorption or After Gastric Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Michael F. Holick, Boston University:

Primary Outcome Measures:
  • # of Pts w/ Enhanced Vitamin D Status [ Time Frame: Baseline, Months 1, 2, 3 ]
    Increase circulating 25(OH)D levels


Enrollment: 19
Study Start Date: March 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 2
Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week
Device: Sperti Lamp
UV light exposure 3 times per week for 12 weeks
Active Comparator: Group 1
Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week
Device: Sperti Lamp
UV light exposure 3 times per week for 12 weeks

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women, age 18 years or older with skin types 2,3,4 and 5.
  2. The patient has an established diagnosis of conditions that have been associated with fat malabsorption due to bowel disease (Crohn's disease, ulcerative colitis, or cystic fibrosis), or history of gastric bypass surgery that at least 3 months post-surgery with no continuing complications.
  3. The patient is able to understand the information provided to them and who have given written informed consent to the study.
  4. The patient is able to understand and complete self-administered questionnaires.
  5. The patient is able and willing to follow study procedures.
  6. If female, the patient is either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptive; intrauterine device; barrier and spermicide or abstinence). Patients must agree to use adequate contraception during the study.

Exclusion Criteria:

  1. Treatment with pharmacologic doses of vitamin D3, vitamin D3 metabolites or analogues, ongoing or within 30 days prior the start of the study.
  2. Pregnancy and lactation.
  3. History of underlying photosensitivity.
  4. Patients with a history of chronic kidney disease or severe liver dysfunction that would alter their calcium and vitamin D metabolism.
  5. Subjects with skin type I (who will develop skin burns after UVB exposure).
  6. Use of medications that cause a photosensitivity reaction including hydrochlorothiazide or tetracycline.
  7. History of skin cancer .
  8. Patients with history of hypocalcemia (calcium <8.6mg%), hypercalcemia (calcium >10.4mg%).
  9. Taking drugs known to influence vitamin D metabolism, such as glucocorticoids and antiseizure medications.
  10. Patients with a history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease within 3 months.
  11. Patients who have travelled through a warm sunny climate without using sunscreen within 1 month of the beginning of the study, or plan to do so during the study period.
  12. Patients who taking any medications which causes skin sensitivity to sunlight (certain antibiotics; retin-A cream used for acne).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910792


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Michael F Holick, PhD, MD BUMC
  More Information

Responsible Party: Michael F. Holick, PhD, MD, Boston University
ClinicalTrials.gov Identifier: NCT01910792     History of Changes
Other Study ID Numbers: H-30047
First Submitted: June 25, 2012
First Posted: July 30, 2013
Results First Submitted: April 6, 2017
Results First Posted: June 14, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Vitamin D Deficiency
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Intestinal Diseases
Metabolic Diseases
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents