An interventional study of Ergocalciferol and Calcitriol in Vitamin D Deficiency, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-19.
Sponsored by Massachusetts General Hospital · Not applicable and Interventional
Fibroblast growth factor 23 (FGF23) is a new hormone which controls phosphate and vitamin D levels in humans. Excess FGF23 is associated with an increased risk of death in patients with chronic kidney disease. In this study the investigators are investigating the effects of different forms of vitamin D on FGF23 levels in the blood in order to increase our understanding of how this important hormone works.
Fibroblast growth factor 23 (FGF23) is a novel hormone involved in phosphate and vitamin D physiology. X-linked hypophosphatemia (XLH), autosomal dominant hypophosphatemic rickets (ADHR), and tumor induced osteomalacia (TIO) are 3 rare diseases characterized by rickets/osteomalacia, fractures, and hypophosphatemia secondary to renal phosphate wasting and inappropriately low levels of activated vitamin D (calcitriol), which are caused by excess amounts of or mutated FGF23. FGF23 excess also occurs in renal failure, where elevated FGF23 levels predict increased mortality. Thus, abnormal FGF23 appears to be central to both rare and common diseases. While FGF23 appears to be regulated by vitamin D, dietary and serum phosphate, much is still unknown. The effects of different forms of vitamin D on FGF23 stimulation are not well characterized. Similarly, any racial differences in the regulation of FGF23 by vitamin D have not been investigated.
To address these knowledge deficits, we will randomize 52 vitamin D deficient (25OHD \< or = 24 ng/mL by LC/MS) Caucasian and African-American men and women to treatment with either dietary vitamin D or activated vitamin D for 12 weeks. Our primary endpoint will be the change in FGF23 with dietary versus activated vitamin D.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 42 is below 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 12 weeks
Dietary Supplement: Ergocalciferol
Daily calcitriol for 12 weeks
Dietary Supplement: Calcitriol
Ergocalciferol 50000 international units by mouth weekly for 12 weeks
Calcitriol 0.5 mcg by mouth daily for 12 weeks
Change in FGF23 levels
Time frame: 12 weeks
Change in serum phosphate
Time frame: 12 weeks
Change in urinary phosphate
Time frame: 12 weeks
Change in serum calcium
Time frame: 12 weeks
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital