Fibroblast growth factor 23 (FGF23) is a newly discovered hormone which regulates phosphate and vitamin D levels. In this study, we are looking at what the normal levels of FGF23 are in adolescent girls and how these levels vary with other hormonal measurements. We will also be looking at whether vitamin D supplementation in adolescents who are deficient in vitamin D alters the levels of FGF23 and other factors including insulin resistance.
Fibroblast growth factor 23 (FGF23) is a newly discovered hormone. Its primary function is to regulate phosphate metabolism, which it does both by directly regulating phosphate excretion through the kidney as well as by regulating vitamin D activity. What controls FGF23 levels is still under investigation; potential factors include dietary phosphate intake and vitamin D levels. In this pilot study, we aim to investigate what the normal levels of FGF23 are in healthy girls and how these are related to other measurements of bone and mineral metabolism. Since vitamin D deficiency is very common in healthy girls, we expect a subset of the subjects in this study to be vitamin D deficient. We will then randomize these girls to vitamin D repletion or placebo and follow changes in FGF23 levels. Vitamin D deficiency has also been implicated in insulin resistance which is a precursor to diabetes. We will therefore also look at changes in insulin resistance with vitamin D repletion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
90
ergocalciferol (a dietary form of vitamin D). 50,000 units by mouth once a week for 16 weeks.
placebo pill once weekly for 16 weeks. At the end of the study, subjects in this arm will receive vitamin D repletion
Massachusetts General Hospital
Boston, Massachusetts, United States
change in FGF23 level with vitamin D repletion
Time frame: baseline and 16 weeks
change in bone turnover markers with vitamin D repletion
Time frame: baseline and 16 weeks
change in mineral metabolism factors with vitamin D repletion
Time frame: baseline and 16 weeks
change in insulin sensitivity with vitamin D repletion
Time frame: baseline and 16 weeks
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