Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents

NCT00994396 | Completed

• 1 other identifier: 1139897
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' project will study the effects of optimizing the vit D status of obese adolescents on markers of glucose metabolism and inflammation.

Conditions

Obesity; Glucose Intolerance; Inflammation

Outcome Measures

Primary Outcomes (3)

• serum 25-hydroxy vitamin D concentrations

  baseline, 3, 6 months

• serum concentrations of inflammatory markers (Interleukin-6, TNF-alpha, c reactive protein)

  baseline and 6 mos

• Hemoglobin A1C, serum glucose and insulin concentrations

  baseline, 3 and 6 months

Secondary Outcomes (2)

• Body composition as measured by DXA

  baseline and 6 mos

• Body mass index

  baseline, 3 and 6 months

Study Arms (2)

Placebo pill

PLACEBO COMPARATOR

Placebo soft gel pills (soy bean oil encapsulated in soft gel comprised of gelatin, glycerin and water) twice per day for 6 mos

Dietary Supplement: Placebo

Vitamin D

EXPERIMENTAL

4000 IU vitamin D3 (cholecalciferol) per day for 6 months.

Dietary Supplement: Vitamin D 3 cholecalciferol

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo soft gel pills (soy bean oil encapsulated in soft gel comprised of gelatin, glycerin and water) twice per day for 6 mos.

Also known as: Reliance Private Label Supplements

Placebo pill

Vitamin D 3 cholecalciferol DIETARY_SUPPLEMENT

4000 IU (2 soft gels at 2000 IU each) vitamin D3 per day for 6 months.

Also known as: Reliance Private Label Supplements

Vitamin D

Eligibility Criteria

• Age: 9 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Obese adolescent (BMI \> 85th percentile for age)
• years of age
• attending the ADOBE clinic at the University of Missouri

You may not qualify if:

• use of vit D supplements other than standard multi-vitamin preparation
• (i.e., should not be receiving vit D \> 1000 IU/d) use of medications that interfere with vit D metabolism (e.g., anti-convulsive)
• history of hepatic or renal disorders;
• undergoing ultraviolet radiation as medical therapy;
• pregnancy;
• cigarette smoking;
• current use of commercial tanning bed;

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

• Belenchia AM, Tosh AK, Hillman LS, Peterson CA. Correcting vitamin D insufficiency improves insulin sensitivity in obese adolescents: a randomized controlled trial. Am J Clin Nutr. 2013 Apr;97(4):774-81. doi: 10.3945/ajcn.112.050013. Epub 2013 Feb 13.

  PMID: 23407306 DERIVED

MeSH Terms

Conditions

Obesity; Glucose Intolerance; Inflammation

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Catherine A Peterson, Ph.D.

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2009
• First Posted: October 14, 2009
• Study Start: November 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2013
• Last Updated: October 6, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)