Personalized Vitamin D Supplementation in European and African Americans
Vitamin D deficiency is associated with many adverse health outcomes and is more prevalent in individuals of African ancestry than in those of European ancestry. Treatment of vitamin D deficiency in both clinical and research settings has focused on the administration of a fixed dose of vitamin D. This investigator-initiated, intramurally-funded, randomized, double-blind, controlled trial of >300 post-menopausal women of European and African descent aims to validate an algorithm for personalized vitamin D dose. (NCT02362269)
INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)
This investigator-initiated, federally-funded, phase III clinical trial will enroll more than 9,000 high-risk cardiovascular subjects to assess the cardiopulmonary benefit of high- versus standard-dose influenza vaccine.
Phase 2 Study of Glycomacropeptide vs. Amino Acid Diet for the Management of PKU.
Phenylketonuria (PKU) is a rare autosomal recessive metabolic disorder affecting one in 10,000 people in the United States. Individuals with PKU lack an enzyme needed to metabolize phenylalanine and must follow a strict diet to prevent cognitive impairment and brain damage. This investigator-initiated, FDA-funded trial will enroll 35 subjects to compare a traditional PKU diet to one comprised of foods and beverages made with glycomacropeptide (GMP), a protein produced during cheese making that contains minimal phenylalanine. (NCT01428258)
Phase 2a Study of Interferon Gamma-1b for the Treatment of Autosomal Dominant Type 2 Osteopetrosis (ADO2).
ADO2, also known as “marble bone disease”, is a rare autosomal dominant disorder characterized by dense, brittle bones. This open-label treatment trial of 30 ADO2 patients will evaluate if administrative of interferon Gamma-1b (Actimmune®) increases biochemical markers of bone turnovers. (NCT02584608)