Vitamin D and Glucose Metabolism in Pediatrics

Obesity Clinical Trial

Official title:

Vitamin D Concentrations and Their Effect on Glucose Metabolism in Pediatrics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01386736
• Other study ID #: 0902010250
• Status: Recruiting
• Phase: Phase 4
• First received: April 18, 2011
• Last updated: June 30, 2011
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2011
• Source: Weill Medical College of Cornell University
• Contact: Maria Vogiatzi, MD
• Phone: 212-746-3462
• Email: mvogiatz[@]med.cornell.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

1. BMI>85th% for age & sex

2. Vitamin D25 between 10-20ng/ml

3. Normal serum Ca concentrations >8.5mg/dl

4. Evidence of insulin resistance (measured by HOMA-IR, and QUICKI indices)

Exclusion Criteria:

1. Vitamin D25<10ng/ml

2. No parental consent

3. No evidence of insulin resistance

4. BMI < 85th percentile

5. Known diagnosis of type 1 or 2 diabetes

6. Severe underlying disease such as liver disease, end-stage renal disease, or malignancy

7. Present medication that affects insulin sensitivity such as steroids or Metformin

8. Any chronic illness or administration of medications that is associated with fat malabsorption as they may interfere with vitamin D absorption.

9. Known history of hypocalcemia, calcium disorder (such as Di George syndrome)

10. Serum Calcium concentration < 8.5mg/dl

11. Other drugs that might effect vitamin D metabolism due to induction of P450 enzyme activity.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Vitamin D25 Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review. — View Citation

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. — View Citation

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. Epub 2005 Mar 1. — View Citation

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. — View Citation

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. — View Citation

Palomer X, González-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. Review. — View Citation

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. Epub 2007 Mar 27. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To quantify the associations between vitamin D 25 concentration, insulin resistance, and calcium metabolism in overweight children.	The normal values for vitamin D are not standardized. In children, it is generally accepted, that vitamin D25 levels>20ng/ml are indicative of vitamin D sufficiency. Data in adults, however, suggest that this cutoff for vitamin D sufficiency should be raised to greater than 30ng/ml. Analysis of bone metabolism in this study will give some insight to the effects of vitamin D treatment in this population of children, and may help further define acceptable vitamin D levels in determining vitamin D deficiency and insufficiency. Our timeframe is baseline and 4 months.	4 months	No