NCT01386736

Brief Summary

The discovery that the vitamin D receptor is expressed in more than 30 tissues indicates that the physiologic functions of vitamin D are much broader than its well-known role in the regulation of calcium absorption and bone metabolism. There is evidence that vitamin D is involved in the pathogenesis of cancer, cardiovascular disease, multiple sclerosis, and type I diabetes. Recent epidemiological evidence points to a strong association between vitamin D insufficiency and insulin resistance, the metabolic syndrome, and type II diabetes. The investigators would like to examine the role of vitamin D in the development of insulin resistance in overweight children and adolescents, which represent a high risk population for cardiovascular and metabolic complications. The investigators propose a prospective randomized clinical trial of vitamin D supplementation in overweight, insulin resistant, vitamin D deficient children. The investigators objective is to assess if changes in insulin resistance, fasting lipid profiles, blood pressure, and inflammatory markers occur in these patients post treatment with vitamin D. Additionally, concomitant changes in calcium and bone metabolism after vitamin D treatment will be evaluated. This is because, contrary to adults, the optimal vitamin D concentrations that regulate calcium and bone metabolism have not been established in pediatrics.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

Enrollment Period

11 months

First QC Date

April 18, 2011

Last Update Submit

June 30, 2011

Conditions

Insulin ResistanceObesityVitamin D25 Insufficiency

Keywords

insulin resistanceobesityadolescencevitamin D supplementation

Outcome Measures

Primary Outcomes (1)

  • To determine changes in insulin sensitivity induced by vitamin D supplementation in obese children with insulin resistance.

    To our knowledge, there are no prospective randomized clinical trials on examining the effects of vitamin D treatment on insulin resistance and bone metabolism in vitamin D deficient, insulin resistant, obese children. We would like to determine if giving Vitamin D supplementation to obese children will help reduce their insulin resistance. We plan to measure Vitamin D levels and HOMA-IR at baseline and compare this to levels post-supplementation. Our timeframe is baseline and 4 months.

    4 months

Secondary Outcomes (1)

  • To quantify the associations between vitamin D 25 concentration, insulin resistance, and calcium metabolism in overweight children.

    4 months

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Subjects will randomly be assigned to Vitamin D drops versus placebo drops.

Drug: Vitamin D drops

Placebo

PLACEBO COMPARATOR

Subjects will randomly be assigned to Vitamin D drops versus placebo drops.

Drug: Placebo drops

Interventions

Vitamin D dropsDRUG

Subjects will be randomly assigned to Vitamin D 3,000 Units per day or Placebo drops.

Vitamin D
Placebo dropsDRUG

Subjects will be randomly assigned to Vitamin D 3,000 Units per day or Placebo drops.

Placebo

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • BMI\>85th% for age \& sex
  • Vitamin D25 between 10-20ng/ml
  • Normal serum Ca concentrations \>8.5mg/dl
  • Evidence of insulin resistance (measured by HOMA-IR, and QUICKI indices)

You may not qualify if:

  • Vitamin D25\<10ng/ml
  • No parental consent
  • No evidence of insulin resistance
  • BMI \< 85th percentile
  • Known diagnosis of type 1 or 2 diabetes
  • Severe underlying disease such as liver disease, end-stage renal disease, or malignancy
  • Present medication that affects insulin sensitivity such as steroids or Metformin
  • Any chronic illness or administration of medications that is associated with fat malabsorption as they may interfere with vitamin D absorption.
  • Known history of hypocalcemia, calcium disorder (such as Di George syndrome)
  • Serum Calcium concentration \< 8.5mg/dl
  • Other drugs that might effect vitamin D metabolism due to induction of P450 enzyme activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

RECRUITING

Related Publications (12)

  • Alemzadeh R, Kichler J, Babar G, Calhoun M. Hypovitaminosis D in obese children and adolescents: relationship with adiposity, insulin sensitivity, ethnicity, and season. Metabolism. 2008 Feb;57(2):183-91. doi: 10.1016/j.metabol.2007.08.023.

    PMID: 18191047BACKGROUND

  • Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

    PMID: 17634462BACKGROUND

  • Chiu KC, Chu A, Go VL, Saad MF. Hypovitaminosis D is associated with insulin resistance and beta cell dysfunction. Am J Clin Nutr. 2004 May;79(5):820-5. doi: 10.1093/ajcn/79.5.820.

    PMID: 15113720BACKGROUND

  • Smotkin-Tangorra M, Purushothaman R, Gupta A, Nejati G, Anhalt H, Ten S. Prevalence of vitamin D insufficiency in obese children and adolescents. J Pediatr Endocrinol Metab. 2007 Jul;20(7):817-23. doi: 10.1515/jpem.2007.20.7.817.

    PMID: 17849744BACKGROUND

  • Munns C, Zacharin MR, Rodda CP, Batch JA, Morley R, Cranswick NE, Craig ME, Cutfield WS, Hofman PL, Taylor BJ, Grover SR, Pasco JA, Burgner D, Cowell CT; Paediatric Endocrine Group; Paediatric Bone Australasia. Prevention and treatment of infant and childhood vitamin D deficiency in Australia and New Zealand: a consensus statement. Med J Aust. 2006 Sep 4;185(5):268-72. doi: 10.5694/j.1326-5377.2006.tb00558.x.

    PMID: 16948623BACKGROUND

  • Keskin M, Kurtoglu S, Kendirci M, Atabek ME, Yazici C. Homeostasis model assessment is more reliable than the fasting glucose/insulin ratio and quantitative insulin sensitivity check index for assessing insulin resistance among obese children and adolescents. Pediatrics. 2005 Apr;115(4):e500-3. doi: 10.1542/peds.2004-1921. Epub 2005 Mar 1.

    PMID: 15741351BACKGROUND

  • Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, Quon MJ. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab. 2000 Jul;85(7):2402-10. doi: 10.1210/jcem.85.7.6661.

    PMID: 10902785BACKGROUND

  • Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.

    PMID: 10480510BACKGROUND

  • Radikova Z, Koska J, Huckova M, Ksinantova L, Imrich R, Vigas M, Trnovec T, Langer P, Sebokova E, Klimes I. Insulin sensitivity indices: a proposal of cut-off points for simple identification of insulin-resistant subjects. Exp Clin Endocrinol Diabetes. 2006 May;114(5):249-56. doi: 10.1055/s-2006-924233.

    PMID: 16804799BACKGROUND

  • Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. doi: 10.1210/jc.2007-0298. Epub 2007 Mar 27.

    PMID: 17389701BACKGROUND

  • Palomer X, Gonzalez-Clemente JM, Blanco-Vaca F, Mauricio D. Role of vitamin D in the pathogenesis of type 2 diabetes mellitus. Diabetes Obes Metab. 2008 Mar;10(3):185-97. doi: 10.1111/j.1463-1326.2007.00710.x.

    PMID: 18269634BACKGROUND

  • Forouhi NG, Luan J, Cooper A, Boucher BJ, Wareham NJ. Baseline serum 25-hydroxy vitamin d is predictive of future glycemic status and insulin resistance: the Medical Research Council Ely Prospective Study 1990-2000. Diabetes. 2008 Oct;57(10):2619-25. doi: 10.2337/db08-0593. Epub 2008 Jun 30.

    PMID: 18591391BACKGROUND

MeSH Terms

Conditions

Insulin ResistanceObesity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Vogiatzi, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Vogiatzi, MD

CONTACT

212-746-3462mvogiatz@med.cornell.edu

Sadana Balachandar, MD

CONTACT

212-746-3462sab9082@nyp.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2011

First Posted

July 1, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations

US(1)