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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT03686150
Eligibility Criteria:
Inclusion Criteria:
* Body mass index greater than or equal to 85% for age and sex
* Physician-diagnosed asthma
* Ongoing relationship with asthma provider responsible for asthma care
* Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit based on local laboratory test
* Ability to swallow pills similar in size to the vitamin D preparation to be used
* Signed consent form from parent, legal guardian or caregiver and signed assent from participant (as appropriate)
* Females of childbearing years must not be pregnant, must not be lactating and must agree to practice adequate birth control method
* Child and parent, legal guardian, or caregiver must speak English or Spanish
Exclusion Criteria:
* Known diseases of calcium metabolism or the parathyroid
* History of renal insufficiency or kidney stones
* Known liver failure or history of abnormal liver function tests
* History of Williams syndrome, sarcoidosis, or granulomatous disease
* Active tuberculosis
* Spot urine calcium/creatinine ration greater than 0.37 (calcium and creatinine measured in mg/ml). This can be repeated following adequate hydration
* Clinical evidence of rickets
* Taking supplemental vitamin D greater than equal to 1000 IU per day
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT03686150
Study Brief:
Protocol Section:
NCT03686150