An interventional study of ergocalciferol and placebo pill in Healthy and Vitamin D Deficiency, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to female participants aged 9 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-05.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Basic science
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.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 90 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Weekly ergocalciferol for 16 weeks
Dietary Supplement: ergocalciferol
Placebo pill. Note that all subjects in this arm will receive vitamin D repletion at the conclusion of the study.
Other: placebo pill
ergocalciferol (a dietary form of vitamin D). 50,000 units by mouth once a week for 16 weeks.
Also known as: vitamin D
placebo pill once weekly for 16 weeks. At the end of the study, subjects in this arm will receive vitamin D repletion
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
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital