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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01399151
Eligibility Criteria:
Inclusion Criteria:
* Age 20-49 (men) and 20-45 (women)
* BMI 18.5-30
* Serum 25OH Vitamin D 25-50 nmol/L
Exclusion Criteria:
* Pregnant or nursing women
* Daily smoker
* Anemia (Hgb\<12 mg/dL for women and \<13 mg/dL for men) determined at initial visit
* Any report or diagnosis of disease or chronic condition that may affect vitamin D absorption such as cystic fibrosis, celiac disease, surgical removal of part of the stomach or intestines, and some forms of liver disease
* Diagnosis of hyper parathyroidism and chronic granulomatous disease, which increases risk of hypercalcemia.
* Planned to travel to a location at which either altitude or latitude would result in significant vitamin D synthesis during the study period.
* Not previously vaccinated with TT, or vaccinated within five years
* Use of steroids or antibiotics within the past 4 weeks
* Current use of nutritional supplements that may alter immune function such as omega 3 fatty acid supplements
* Current use of anti-inflammatory or anti-convulsion medications
* Self reported history of significant adverse response to previous vaccinations
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
49 Years
Study:
NCT01399151
Study Brief:
Protocol Section:
NCT01399151