Vitamin D Deficiency, Insulin Resistance and FGF-23

NCT00491322 | Completed Results DMC

• 2 other identifiers: 2006-P-000430/18K23DK073356
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to determine if treating vitamin D deficiency decreases insulin resistance and improves insulin secretion in healthy volunteers. Additionally, this project will investigate if treating vitamin D deficiency affects a new phosphate-regulating hormone called FGF-23.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D; Vitamin D deficiency; Insulin resistance; Diabetes; Diabetes mellitus; FGF-23; FGF23; Phosphate

Outcome Measures

Primary Outcomes (1)

• Fibroblast Growth Factor 23 (FGF23) After 12 Weeks of Weekly Ergocalciferol 50000 Units

  Fibroblast growth factor 23 (FGF23) is a phosphate and vitamin D regulating hormone.

  12 weeks

Study Arms (2)

Ergocalciferol group

EXPERIMENTAL

Ergocalciferol 50000 international units once a week for 12 weeks

Dietary Supplement: Ergocalciferol

Ergocalciferol Placebo group

PLACEBO COMPARATOR

Matching placebo once a week for 12 weeks

Dietary Supplement: Ergocalciferol placebo

Interventions

Ergocalciferol DIETARY_SUPPLEMENT

Ergocalciferol 50000 international units once a week for 12 weeks

Ergocalciferol group

Ergocalciferol placebo DIETARY_SUPPLEMENT

Ergocalciferol placebo once a week for 12 weeks

Ergocalciferol Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 45 yrs
• Serum 25-OHD \< or = 20 ng/mL
• At least 1 menses in the last 3 months (females) and normal serum testosterone (males)

You may not qualify if:

• Significant cardiac, hepatic, oncologic, or psychiatric disease
• History of diabetes mellitus, malabsorption, kidney stones, or recent alcohol excess/abuse (15 drinks per week in the last month)
• Fasting glucose \> 126 mg/dl or 2 hour OGTT \> 200 mg/dl
• Use of medications known 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 A (\> 20,000 units/day), calcitriol, growth hormone, or anti-convulsants
• Use of metformin or insulin sensitizing agents
• Serum calcium \< 8 or \> 11 mg/dL, creatinine \> 1.5 mg/dL, or Hgb \< 11 gm/dL
• Liver function tests \> 2 times the upper limit of normal
• TSH \< 0.1 or \> 7 uU/mL
• WBC \< 2,000 or \> 15,000/cmm
• Platelet count \< 100,000 or \> 500,000/cum
• Hormone replacement therapy or testosterone use
• Urine uhCG positive (females), testosterone \< 270 ng/dL (males)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• 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

• 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-Bowie SA, Leder BZ, Henao MP, Baldwin CM, Hayden DL, Finkelstein JS. Randomized trial assessing the effects of ergocalciferol administration on circulating FGF23. Clin J Am Soc Nephrol. 2012 Apr;7(4):624-31. doi: 10.2215/CJN.10030911. Epub 2012 Feb 2.

  PMID: 22300739 RESULT

• Mitchell DM, Leder BZ, Cagliero E, Mendoza N, Henao MP, Hayden DL, Finkelstein JS, Burnett-Bowie SA. Insulin secretion and sensitivity in healthy adults with low vitamin D are not affected by high-dose ergocalciferol administration: a randomized controlled trial. Am J Clin Nutr. 2015 Aug;102(2):385-92. doi: 10.3945/ajcn.115.111682. Epub 2015 Jul 8.

  PMID: 26156733 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Insulin Resistance; Diabetes Mellitus

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Sherri-Ann M. Burnett-Bowie
• Organization: Massachusetts General Hospital

sburnett-bowie@mgh.harvard.edu

6177245594

Study Officials

• Sherri-Ann M Burnett-Bowie, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 26, 2007
• Study Start: May 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 2, 2018
• Results First Posted: May 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)