Vitamin D Deficiency in Adolescent Girls
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|ClinicalTrials.gov Identifier: NCT01180946|
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : November 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy Vitamin D Deficiency||Dietary Supplement: ergocalciferol Other: placebo pill||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Vitamin D Deficiency in Adolescent Girls|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Active Comparator: Ergocalciferol
Weekly ergocalciferol for 16 weeks
Dietary Supplement: ergocalciferol
ergocalciferol (a dietary form of vitamin D). 50,000 units by mouth once a week for 16 weeks.
Other Name: vitamin D
Placebo Comparator: Placebo
Placebo pill. Note that all subjects in this arm will receive vitamin D repletion at the conclusion of the study.
Other: placebo pill
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180946
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Sherri-Ann Burnett-Bowie, MD, MPH||Massachusetts General Hospital|