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Vitamin D Deficiency in Adolescent Girls

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sherri-Ann M. Burnett-Bowie, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01180946
First received: August 11, 2010
Last updated: November 1, 2013
Last verified: November 2013

August 11, 2010
November 1, 2013
September 2010
April 2013   (final data collection date for primary outcome measure)
change in FGF23 level with vitamin D repletion [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
change in FGF23 level with vitamin D repletion [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01180946 on ClinicalTrials.gov Archive Site
  • change in bone turnover markers with vitamin D repletion [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • change in mineral metabolism factors with vitamin D repletion [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: Yes ]
  • change in insulin sensitivity with vitamin D repletion [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • change in insulin resistance with vitamin D repletion [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • change in bone turnover markers with vitamin D repletion [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • change in mineral metabolism factors with vitamin D repletion [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Vitamin D Deficiency in Adolescent Girls
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Healthy
  • Vitamin D Deficiency
  • 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
  • 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
  • Active Comparator: Ergocalciferol
    Weekly ergocalciferol for 16 weeks
    Intervention: Dietary Supplement: ergocalciferol
  • Placebo Comparator: Placebo
    Placebo pill. Note that all subjects in this arm will receive vitamin D repletion at the conclusion of the study.
    Intervention: Other: placebo pill

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Female
9 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01180946
2010-P-001126/1
Yes
Sherri-Ann M. Burnett-Bowie, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Sherri-Ann Burnett-Bowie, MD, MPH Massachusetts General Hospital
Massachusetts General Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP