Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT01910792
Eligibility 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01910792
Study Brief:
Protocol Section:
NCT01910792