An interventional study of 4,000 IU vitamin D3 in Insulin Resistance, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 9 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-10.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
Childhood obesity is a rapidly growing epidemic in the US and the world. Current estimates suggest that 30% of our nation's children are either overweight ot obese. Obesity is a major risk factor towards the development of insulin resistance, which, in turn is a major risk factor for the development of type 2 diabetes. Prior research has suggested that vitamin D therapy may be a safe, inexpensive, and effective method of reducing insulin resistance and a person's risk of developing diabetes.
The investigators' prior studies have shown that daily 4,000 IU vitamin D therapy is a safe and effective method of improving insulin resistance based on a calculation called the HOMA-IR.
The next step in identifying whether vitamin D truly improves insulin resistance is to use oral glucose tolerance testing (OGTT), which is a better real-life measure of insulin resistance compared to the previously used HOMA-IR.
The investigators intend to recruit 20 obese adolescent subjects from the PI's obesity clinic to participate in the study. Investigators expect 5 to drop out, therefore leaving 15 subjects to complete the study. Eligible and assenting subjects (with consent from a parent) will be admitting to the Pediatric Procedure Suite and MU Women's and Children's Hospital. They will have an IV placed in the arm by a nurse experienced with working with children. The subjects will have blood drawn from the IV checking for vitamin D level, insulin, glucose, and c-peptide level (another marker for insulin status). The subject will then be asked to drink a 75 gram glucose solution. Additional blood will be drawn from the IV site to check for glucose, insulin, and c-peptide levels at 30 minutes, 60 minutes, 90 minutes, and 120 minutes. A total of 30 mL (2 tablespoons) of blood will be drawn that day. The subject will have the IV removed and will be discharged to then take two 2,000 IU vitamin D3 pills (total 4,000 IU) daily for six months.
At a routine 3 months clinical visit, the subject will be tested for routine, standard of care, basic metabolic profile (BMP) with 4 ml of blood (less than 1 teaspoon) to assess for high calcium levels, a potential complication of vitamin D therapy. In the investigators' previous study of adolescents taking 4,000 IU vitamin D daily for six months, no subject developed a high calcium level.
At six months, the subject will return to the Pediatric procedure suite to have another OGTT and labs via IV as described above.
1,959 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.
This study's enrollment of 15 is below the median of 40 across 1,535 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
two 2,000 IU vitamin D3 pills (total 4,000 IU) daily for six months.
Dietary Supplement: 4,000 IU vitamin D3
two 2,000 IU vitamin D3 pills (total 4,000 IU) daily for six months.
change in oral glucose tolerance
Will obtain oral glucose tolerance tests at baseline and at 6 months to determine change
Time frame: baseline and 6 months
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Missouri-Columbia