Status:
COMPLETED
Ultraviolet Light And Vitamin D In Subjects With Fat Malabsorption Or After Gastric Bypass Surgery
Lead Sponsor:
Boston University
Conditions:
Vitamin D Deficiency
Gastrointestinal Diseases
Eligibility:
All Genders
18-64 years
Phase:
NA
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 vi...
Detailed Description
Given that vitamin D is absorbed in the proximal small intestine, it is believed that vitamin D deficiency in people with a fat malabsorption syndrome may be due to decreased absorption of vitamin D. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01910792
Start Date
March 1 2011
End Date
February 1 2014
Last Update
July 11 2017
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118