Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT01180946
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.
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Notify Me9 year–18 year
Female
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ergocalciferol (a dietary form of vitamin D). 50,000 units by mouth once a week for 16 weeks.
Other names: vitamin D
placebo pill once weekly for 16 weeks. At the end of the study, subjects in this arm will receive vitamin D repletion
Time frame: baseline and 16 weeks
Time frame: baseline and 16 weeks
Time frame: baseline and 16 weeks
Time frame: baseline and 16 weeks
Massachusetts General Hospital
Other
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