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:
NCT02387892
Eligibility Criteria:
Inclusion Criteria:
* Children 2 through 8 years of age;
* Healthy body weight for age.
Exclusion Criteria:
* Regular use of vitamin D supplements;
* Lactose intolerant;
* Don't drink milk or eat cheese or yogurt;
* Prior treatment for biochemically confirmed vitamin D deficiency;
* Known or suspected medical conditions associated with bone and vitamin D including rickets, osteomalacia, liver disease, renal disease, immobilization (complete or partial), fractures, and disorders of the parathyroid gland;
* Known or suspected chronic illness of childhood, such as asthma, cancer, Crohn's disease, nephrotic syndrome, rheumatic conditions, and diabetes, etc;
* Use in the past 3 months of medications known to affect bone and/or mineral ion metabolism including oral/systemic/inhaled glucocorticoids, phosphate therapy or vitamin D analogues. Bisphosphonates are also included in this category;
* however, because of their long-half lives and persistence in bone tissue, any prior use of bisphosphonate therapy precludes enrolment;
* Conditions in which the procurement of 8 ml of blood would compromise the health of the patient (i.e. patients with severe anemia).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
8 Years
Study:
NCT02387892
Study Brief:
Protocol Section:
NCT02387892