Phase 1 N=12 Randomized Quadruple-blind Basic Science

Effect of Vitamin D Replacement on Insulin Sensitivity

Insulin Sensitivity

Bottom Line

View on ClinicalTrials.gov: NCT01268111 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcome: Primary: M Value (Insulin Stimulated Glucose Uptake) — 4.1; 5.6; 4.7; 5.5 mg/kg.min — p=0.4

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Ergocalciferols (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Texas Tech University Health Sciences Center
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY M Value (Insulin Stimulated Glucose Uptake)	4.1; 5.6; 4.7; 5.5	0.4

Summary

Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before and after the intervention, and the changes will be compared between the two groups. This will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are mediated by RBP4.

Eligibility Criteria

Inclusion Criteria

1. Age 18-60 years 2. No known medical illnesses requiring pharmacotherapy 3. Not on any mineral or vitamin supplements in the last 3 months

Exclusion Criteria

1. Subjects requiring prompt initiation of pharmacotherapy, such as those with incidentally discovered diabetes mellitus or hypertension.
Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months.
Bariatric surgery or liposuction 4. Unintentional weight loss >5% of the body weight in last 3 months 5. Chronic smokers (> 1 pk/d for 10 years) 6. Alcohol use > 2 drinks/day

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Data sourced from ClinicalTrials.gov (NCT01268111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.