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Completed

NCT Number: NCT01180946

Vitamin D Deficiency in Adolescent Girls

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.

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Key information

Age range

9 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ergocalciferol

Dietary Supplement

ergocalciferol (a dietary form of vitamin D). 50,000 units by mouth once a week for 16 weeks.

Other names: vitamin D

Placebo pill

Other

placebo pill once weekly for 16 weeks. At the end of the study, subjects in this arm will receive vitamin D repletion

Primary outcomes

  1. change in FGF23 level with vitamin D repletion

    Time frame: baseline and 16 weeks

Secondary outcomes

  1. change in bone turnover markers with vitamin D repletion

    Time frame: baseline and 16 weeks

  2. change in mineral metabolism factors with vitamin D repletion

    Time frame: baseline and 16 weeks

  3. change in insulin sensitivity with vitamin D repletion

    Time frame: baseline and 16 weeks

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 12, 2010
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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