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

NCT01910792 | Completed Results FDA Device

• 1 other identifier: H-30047
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin D Deficiency; Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (1)

• # of Pts w/ Enhanced Vitamin D Status

  Increase circulating 25(OH)D levels

  Baseline, Months 1, 2, 3

Study Arms (2)

Group 2

ACTIVE COMPARATOR

Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week

Device: Sperti Lamp

Group 1

ACTIVE COMPARATOR

Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week

Device: Sperti Lamp

Interventions

Sperti Lamp DEVICE

UV light exposure 3 times per week for 12 weeks

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women, age 18 years or older with skin types 2,3,4 and 5.
• 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.
• The patient is able to understand the information provided to them and who have given written informed consent to the study.
• The patient is able to understand and complete self-administered questionnaires.
• The patient is able and willing to follow study procedures.
• 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.

You may not qualify if:

• Treatment with pharmacologic doses of vitamin D3, vitamin D3 metabolites or analogues, ongoing or within 30 days prior the start of the study.
• Pregnancy and lactation.
• History of underlying photosensitivity.
• Patients with a history of chronic kidney disease or severe liver dysfunction that would alter their calcium and vitamin D metabolism.
• Subjects with skin type I (who will develop skin burns after UVB exposure).
• Use of medications that cause a photosensitivity reaction including hydrochlorothiazide or tetracycline.
• History of skin cancer .
• Patients with history of hypocalcemia (calcium \<8.6mg%), hypercalcemia (calcium \>10.4mg%).
• Taking drugs known to influence vitamin D metabolism, such as glucocorticoids and antiseizure medications.
• Patients with a history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease within 3 months.
• 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.
• Patients who taking any medications which causes skin sensitivity to sunlight (certain antibiotics; retin-A cream used for acne).

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Michael F Holick
• Organization: Vitamin D, Skin, and Bone Research Laboratory

mfholick@bu.edu

6176384546

Study Officials

• Michael F Holick, PhD, MD

  BUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: July 30, 2013
• Study Start: March 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 11, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-06

Locations

US (1)