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Trial record 2 of 2 for:    18191047 [PUBMED-IDS]

Correction of Vitamin D Levels and Its Effect on Insulin Resistance and Weight Gain in Obese Youth

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ClinicalTrials.gov Identifier: NCT02168660
Recruitment Status : Unknown
Verified June 2014 by Michele Hutchison, University of Texas Southwestern Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : June 20, 2014
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):
Michele Hutchison, University of Texas Southwestern Medical Center

Brief Summary:

Vitamin D deficiency is extremely common in obese youth. In our obese population followed in the Endocrinology clinic at CMC, vitamin D levels were inversely correlated with a measure of insulin resistance. We propose to show that correction of vitamin D levels in obese children and adolescents improves their insulin sensitivity. Obese youth presenting to the Center for Obesity and its Consequences on Health (COACH) clinic will be randomized to receive either the most recent Institute of Medicine (IOM) recommendations of minimum D3 dose of 600 IU/day (1), or receive higher doses of D3 such that the blood levels of vitamin D will be brought to a target level in either the low part or high part of the normal range. The goal is to determine if correction of vitamin D deficiency will improve insulin sensitivity in this group. Secondary goals include determining whether correction of vitamin D deficiency in obese adolescents and children results in less weight gain, and determining the amount of D3 required to correct vitamin D levels in this population.

Our specific hypotheses are as follows:

Hypothesis #1 Obese youth treated with Vitamin D3 who achieve low-normal 25-OHD levels (30-50 ng/mL) or high-normal 25-OHD levels (60-80 ng/mL) will have improved insulin resistance, as measured by HOMA-IR, compared to those individuals with deficient 25-OHD levels (< 30 ng/mL).

Hypothesis #2 Subjects with a higher BMI will have higher Vitamin D dose requirements than current IOM recommendations of 600 IU/day and will take a longer period of time to reach target 25-OHD levels.

Hypothesis #3 Subjects with normal 25-OHD levels will demonstrate less weight gain compared to subjects on the control arm.


Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Vitamin D Deficiency Drug: Vitamin D3 Phase 2

Detailed Description:

Concise Summary of Project: The proposed study is a prospective, unblinded dose-ranging trial to examine in obese youth 1) the effect of correcting Vitamin D (Vit D) deficiency on insulin resistance, 2) the effect of correcting Vit D deficiency on weight gain, and 3) the amount of Vit D3 required to achieve Vit D sufficiency in obese adolescents. Subjects will be recruited from obese children and adolescents aged 6 to 17 years presenting to the COACH clinic, a referral clinic for obese children at Children's Medical Center of Dallas. Approximately 1300 new patients are seen in the COACH clinic each year. Ethnicity will be self-assigned as African-American, Caucasian, Hispanic, or Other. The ethnic makeup of the COACH clinic over the last 20 months was as follows: African-American 25%, Caucasian 19.5%, Hispanic 52%, and Other 3.5%.

As per standard practice in the COACH clinic, a height (cm), weight (kg), and blood pressure will be obtained, and body mass index (kg/m2) calculated for each patient. Fasting total cholesterol, LDL, HDL, triglyceride, 25-OHD, Hemoglobin A1c (A1c), and fasting insulin will be obtained, and an Oral Glucose Tolerance Test (OGTT) performed. The baseline estimate of insulin sensitivity is calculated from the fasting insulin and glucose values, and reported as the HOMA-IR. After Informed Consent has been obtained, participants will be randomized to either the Control group (5000 IU/wk), the Low-normal 25-OHD group (target 25-OHD 30-50 ng/mL), or the High-normal 25-OHD group (target 25-OHD 60-80 ng/mL). A 25-OHD < 25 ng/mL will be confirmed. These groups will be matched for age (6-12 years versus 13-17 years) and ethnicity (Caucasian versus African-American verus Hispanic). Approximately 60 patients will be recruited for each group. Subject participation will continue until Vit D sufficiency has been documented for 4 consecutive months, at which point the fasting insulin and glucose values will be repeated for calculation of HOMA-IR and assessment of insulin sensitivity, and amount of weight gain will be measured.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Normalization of Vitamin D Levels and Its Effect on Glucose Homeostasis in Obese Youth
Study Start Date : March 2011
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.
Drug: Vitamin D3
Vitamin D3, liquid formulation, 5000 IU/mL.
Other Name: calcidiol

Experimental: Low-Normal Group
Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).
Drug: Vitamin D3
Vitamin D3, liquid formulation, 5000 IU/mL.
Other Name: calcidiol

Experimental: High-Normal Group
Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).
Drug: Vitamin D3
Vitamin D3, liquid formulation, 5000 IU/mL.
Other Name: calcidiol




Primary Outcome Measures :
  1. log delta HOMA-IR versus delta 25-OHD [ Time Frame: end of study (4-12 mo) ]
    Log base 10 of the change in HOMA-IR from initial visit to end of study visit versus the change in serum 25-OH vitamin D levels.


Secondary Outcome Measures :
  1. Time to normalization of Vit D level versus BMI Z score [ Time Frame: 1 to 12 months ]
    The time required to reach a normal Vitamin D level (> 30) versus BMI Z score at each vitamin D3 dose; OR vitamin D level at 6 weeks versus BMI Z score at each starting vitamin D3 dose.

  2. delta BMI Z score versus delta 25-OHD level [ Time Frame: study end, 4-12 months ]
    The change in BMI Z score from initial to study end versus the change in serum 25-OH D level.



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 6-17 years
  • BMI > 95% for age
  • serum 25-OH D level < or + to 25 ng/mL

Exclusion Criteria:

  • BMI < 95% for age
  • serum 25-OH D level > 25 ng/mL
  • current Vitamin D supplementation > 400 IU/day
  • anti-convulsant therapy, anti-hypertensive therapy, lipid lowering medication
  • any medications that affect glucose metabolism (e.g., metformin, insulin)
  • daily glucocorticoid therapy
  • diabetes
  • any disorders of bone or calcium metabolism
  • hepatic or renal disease
  • any malabsorptive disorder
  • baseline serum Calcium > 11 ng/dL (> 2 SD above the mean)
  • any genetic disorder that predisposes to obesity (e.g., Prader Willi
  • hypothalamic obesity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168660


Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Michele R Hutchison, MD, PhD UT Southwestern Medical Center

Publications:

Responsible Party: Michele Hutchison, Assistant professor of Pediatrics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02168660     History of Changes
Other Study ID Numbers: UT092010-217
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014

Keywords provided by Michele Hutchison, University of Texas Southwestern Medical Center:
Obesity
Insulin Resistance
Vitamin D Deficiency
Children
Adolescents

Additional relevant MeSH terms:
Insulin Resistance
Vitamin D Deficiency
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents