Vitamin D Deficiency in Adolescent Girls

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy, Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT01180946

Run by

Massachusetts General Hospital

People needed

90

Starts

2010-09-01

Expected to finish

2013-04-01

Last updated by the study team

2013-11-05

Who can join

Age: 9 and older, up to 18. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• healthy girls aged 9-18 years

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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