Vitamin D Deficiency in Adolescent Girls

NCT01180946 | Completed DMC

• 1 other identifier: 2010-P-001126/1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Vitamin D Deficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• change in FGF23 level with vitamin D repletion

  baseline and 16 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Ergocalciferol

ACTIVE COMPARATOR

Weekly ergocalciferol for 16 weeks

Dietary Supplement: ergocalciferol

Placebo

PLACEBO COMPARATOR

Placebo pill. Note that all subjects in this arm will receive vitamin D repletion at the conclusion of the study.

Other: placebo pill

Interventions

ergocalciferol DIETARY_SUPPLEMENT

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

Also known as: vitamin D

Ergocalciferol

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

Placebo

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• 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.

  PMID: 19419295 BACKGROUND

• 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. doi: 10.1016/j.bone.2006.10.016. Epub 2006 Dec 8.

  PMID: 17157573 BACKGROUND

• Burnett SM, Gunawardene SC, Bringhurst FR, Juppner 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. doi: 10.1359/jbmr.060507.

  PMID: 16869716 BACKGROUND

• Mitchell DM, Juppner 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.

  PMID: 28323960 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Insulin Resistance

Interventions

Ergocalciferols; Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sherri-Ann Burnett-Bowie, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 12, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

US (1)