Vitamin D Deficiency in Adolescent Girls

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; Healthy
• Interventions: Dietary Supplement: ergocalciferol; Other: placebo pill

• Registration Number: NCT01180946
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Study Start: 2010-09
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-01
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ergocalciferol	ergocalciferol	Weekly ergocalciferol for 16 weeks
Placebo	placebo pill	Placebo pill. Note that all subjects in this arm will receive vitamin D repletion at the conclusion of the study.

Primary Outcome Measures

Name	Time	Method
change in FGF23 level with vitamin D repletion	baseline and 16 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States