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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Boston Medical Center
Sponsor:
Information provided by (Responsible Party):
Michael F. Holick, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01910792
First received: June 25, 2012
Last updated: July 26, 2013
Last verified: July 2013
  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: UV lamp

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Boston Medical Center:

Primary Outcome Measures:
  • Enhance Vitamin D Status [ Time Frame: Baseline, Months 1, 2, 3 ] [ Designated as safety issue: No ]
    Increase circulating 25(OH)D levels


Secondary Outcome Measures:
  • Erythema [ Time Frame: Baseline, Months 1, 2, 3 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: February 2014
Estimated 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 use a UV Lamp at home 3x per week.
Device: UV lamp
Exposure to UV lamp 3 times a week for 12 weeks
Active Comparator: Group 1
Patients with fat malabsorption syndromes will use a UV lamp at home 3x per week.
Device: UV lamp
UV light exposure 3 times per week for 12 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910792

Contacts
Contact: Michael F Holick, PhD, MD 617-638-4546 mfholick@bu.edu

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Jaimee M Bogusz, BS    617-638-8860    jmbogusz@bu.edu   
Principal Investigator: Michael F Holick, PhD, MD         
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Michael F Holick, PhD, MD BUMC
  More Information

No publications provided

Responsible Party: Michael F. Holick, PhD, MD, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01910792     History of Changes
Other Study ID Numbers: H-30047
Study First Received: June 25, 2012
Last Updated: July 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D Deficiency
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Intestinal Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014