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NCT07876843
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
Conditions: Hypovitaminosis D
Sex: All
Ages: 6 Years – 21 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 200
Sponsor: Atlantic Health System
Location: Children's Orthopedic and Sports Medicine Center Morristown New Jersey
Summary
Vitamin D is essential for calcium absorption and bone growth, brain development, and immune system function. Vitamin D is produced by the body in response to natural sunlight. In New Jersey, which is not near the equator and where children are indoors for large parts of the year or use of sun block, it is possible that otherwise healthy children may suffer from vitamin D deficiency, placing them at risk for weak bones, fractures and poor bone growth. Larger children are at a higher risk of deficiency. This research is being conducted to identify children in this group with Vitamin D deficiency and determine the amount of vitamin D supplementation necessary for them daily using a protocol developed.
Eligibility Criteria
Inclusion Criteria:
* 6 to 21 years old (inclusive)
* Patients 63.5 kg (140 lbs) and up
* Patients not currently taking vitamin D supplements
Exclusion Criteria:
* History of immunomodulation medication or immune deficiency disease
* History of immune incompetence (does not include diabetes)
* Sickle Cell Disease
* Cancer
* Chronic illness with decreased ambulation or non-ambulatory
* Taking medication that blocks absorption of vitamin D metabolism (glucocorticoids, antiseizure meds, antifungals, antifungals, cholestyramine, antacids and PPI )
* Kidney or Liver disease
* Neuromuscular disease
* Non-weight bearing patients
* Malabsorption (Celiac disease, CF)
* Already Taking vitamin D supplement
Source: ClinicalTrials.gov (NCT07876843). StuddyBuddy aggregates publicly available trial information.