Healthy, Vitamin D Deficiency
Conditions
Keywords
FGF23, FGF-23, vitamin D, vitamin D deficiency, insulin resistance, Healthy volunteers
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTergocalciferol
ergocalciferol (a dietary form of vitamin D). 50,000 units by mouth once a week for 16 weeks.
OTHERplacebo pill
placebo pill once weekly for 16 weeks. At the end of the study, subjects in this arm will receive vitamin D repletion
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy girls aged 9-18 years
Exclusion criteria
* significant cardiac, hepatic, oncologic, or psychiatric disease * a history of malabsorption, kidney stones, hypoparathyroidism, or growth hormone deficiency * pregnancy * diabetes mellitus * BMI\>/= 99th percentile for age and sex * fracture within the preceding 3 months * hypogonadism (no pubertal development by age 12, absence of menarche by age 14) * serum calcium \<8 mg/dl or \>11 mg/dl * radiographic evidence of rickets * use of medications know to affect serum phosphate levels including phosphate-binding antacids, sodium etidronate, calcitonin, excessive doses of vitamin D (\>1000 units per day), excessive doses of vitamin D (\>20,000 units/day), calcitriol, growth hormone, or anti-convulsants. * use of hormonal birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in FGF23 level with vitamin D repletion | baseline and 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| change in bone turnover markers with vitamin D repletion | baseline and 16 weeks |
| change in mineral metabolism factors with vitamin D repletion | baseline and 16 weeks |
| change in insulin sensitivity with vitamin D repletion | baseline and 16 weeks |
Countries
United States
Outcome results
None listed