African American Children, Glycemic Control, and Type 2 Diabetes
Condition: Type 2 Diabetes; Vitamin D Deficiency
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Using a randomized, placebo-controlled trial design in subjects with vitamin D deficiency,
      the investigators propose to determine if vitamin D treatment improves glycemic control in
      vitamin D deficient subjects with T2DM. The investigators hypothesize that oral vitamin D
      treatment will improve glycemic control and ß-cell function in vitamin D deficient AA
      subjects with T2DM. The investigators further hypothesize that maintaining serum 25(OH)D
      concentrations above 20 ng/ml with oral supplementation of vitamin D will have additional
      glycemic control effects.
    

Detailed description: 
      Current literature suggests that 25-hydroxyvitamin D (25(OH)D) is inversely related to risk
      of type 2 diabetes mellitus (T2DM). African Americans (AA) have significantly less 25(OH)D
      concentrations, greater chances of poor glycemic control compared to European Americans (EA).
      The primary objective is to evaluate if the differences in glycemic control in children with
      type 2 diabetes are explained by differences in serum concentrations of 25(OH)D. A secondary
      aim is to demonstrate that subjects with vitamin D deficiency (serum 25(OH)D <20ng/ml) and
      T2DM who receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week)
      have greater improvement than subjects who receive placebo in glycemic control, as measured
      by HbA1c and endogenous insulin secretion, as assessed by area under the concentration-time
      curve (AUC) for mixed meal-stimulated C peptide, at 3 months after study drug administration.
      Research design: Randomized, placebo-controlled, double blind study design in children with
      T2DM and vitamin D deficiency. Glycemic control will be determined by HbA1C levels, fasting
      glucose and area under the curve (AUC) for glucose after a mixed meal tolerance test (MMTT).
      Measures of beta cell function will be determined by AUC for c-peptide and glucose after
      MMTT. This study is warranted in AA adolescents with T2DM as any positive interventions could
      have life long impact and will lead to future larger clinical trials.
    

Intervention name(s): Vitamin D2; Sugar pill
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Subjects with vitamin D deficiency (serum 25(OH)D <20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen.; group: vitamin D2 50000 IU weekly once for 8 weeks
nd group: placebo weekly once for 8 weeks
Other intervention name(s): Group 1: vitamin D2 50000 IU weekly once for 8 weeks
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Vitamin D deficiency; Glycemic control