Vitamin D Deficiency in Adolescent Girls

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ClinicalTrials.gov Identifier: NCT01180946

Recruitment Status : Completed

First Posted : August 12, 2010

Last Update Posted : November 5, 2013

Sponsor:

Information provided by (Responsible Party):

Sherri-Ann M. Burnett-Bowie, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Vitamin D Deficiency	Dietary Supplement: ergocalciferol Other: placebo pill	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Basic Science
Official Title:	Vitamin D Deficiency in Adolescent Girls
Study Start Date :	September 2010
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D Vitamin D Deficiency

Drug Information available for: Ergocalciferol Vitamin D

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ergocalciferol Weekly ergocalciferol for 16 weeks	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
Placebo Comparator: Placebo Placebo pill. Note that all subjects in this arm will receive vitamin D repletion at the conclusion of the study.	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

Outcome Measures

Primary Outcome Measures :

change in FGF23 level with vitamin D repletion [ Time Frame: baseline and 16 weeks ]

Secondary Outcome Measures :

change in bone turnover markers with vitamin D repletion [ Time Frame: baseline and 16 weeks ]
change in mineral metabolism factors with vitamin D repletion [ Time Frame: baseline and 16 weeks ]
change in insulin sensitivity with vitamin D repletion [ Time Frame: baseline and 16 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	9 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180946

Locations

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

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Principal Investigator:	Sherri-Ann Burnett-Bowie, MD, MPH	Massachusetts General Hospital

More Information

Publications:

Burnett-Bowie SM, Henao MP, Dere ME, Lee H, Leder BZ. Effects of hPTH(1-34) infusion on circulating serum phosphate, 1,25-dihydroxyvitamin D, and FGF23 levels in healthy men. J Bone Miner Res. 2009 Oct;24(10):1681-5. doi: 10.1359/jbmr.090406.

Burnett-Bowie SM, Mendoza N, Leder BZ. Effects of gonadal steroid withdrawal on serum phosphate and FGF-23 levels in men. Bone. 2007 Apr;40(4):913-8. Epub 2006 Dec 8.

Burnett SM, Gunawardene SC, Bringhurst FR, Jüppner H, Lee H, Finkelstein JS. Regulation of C-terminal and intact FGF-23 by dietary phosphate in men and women. J Bone Miner Res. 2006 Aug;21(8):1187-96.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mitchell DM, Jüppner H, Burnett-Bowie SM. FGF23 Is Not Associated With Age-Related Changes in Phosphate, but Enhances Renal Calcium Reabsorption in Girls. J Clin Endocrinol Metab. 2017 Apr 1;102(4):1151-1160. doi: 10.1210/jc.2016-4038.

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Responsible Party:	Sherri-Ann M. Burnett-Bowie, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01180946
Other Study ID Numbers:	2010-P-001126/1
First Posted:	August 12, 2010 Key Record Dates
Last Update Posted:	November 5, 2013
Last Verified:	November 2013

Keywords provided by Sherri-Ann M. Burnett-Bowie, Massachusetts General Hospital:


FGF23 FGF-23 vitamin D	vitamin D deficiency insulin resistance Healthy volunteers

Additional relevant MeSH terms:

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Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Ergocalciferols	Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents

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