Effect of Weekly High-dose Vitamin D3 Supplementation on the Association Between Circulatory FGF-23 and A1c Levels
Condition: Diabetes Mellitus, Type 2; Kidney Diseases
MeSH terms: Kidney Diseases; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Among Jordanians, there is a high prevalence of T2DM. VDD has also spread rapidly in the past
      decade. Preliminary results of recent studies have shown that VD3 has a potential role in
      reducing FBG. Notably, the impact of VD3 supplementation on glycemic control in diabetics, as
      well as pre-diabetics, remains highly controversial. Some studies have shown that osteocalcin
      (OSC) is correlated with fat mass, sensitivity to and secretion of insulin, glucose
      metabolism, and glycemic variability. In mice, OSC injections improved insulin sensitivity
      and prevent obesity. A more recent study has found that T2DM was inversely correlated with
      osteocalcin levels . There is a strong correlation between OSC and fibroblastic factor -23
      (FBF-23). Many recent studies have correlated FBF-23 as well as vitamin D levels with some of
      the pathological conditions such as chronic kidney failure, atherosclerosis, and diabetes.
      They stated possible interrelationships between insulin resistance, Hyperinsulinemia, and/or
      lower VD3 levels may lead to decreased serum FGF-23 concentrations in obese children and
      adolescents. Therefore, serum FGF-23 has been suggested to be a potential indicator of
      subclinical atherosclerosis in patients with gestational diabetes mellitus.
    

Detailed description: 
      Among Jordanians, there is a high prevalence of T2DM. VDD has also spread rapidly in the past
      decade. Preliminary results of recent studies have shown that VD3 has a potential role in
      reducing FBG. Notably, the impact of VD3 supplementation on glycemic control in diabetics, as
      well as pre-diabetics, remains highly controversial. Some studies have shown that osteocalcin
      (OSC) is correlated with fat mass, sensitivity to and secretion of insulin, glucose
      metabolism, and glycemic variability. In mice, OSC injections improved insulin sensitivity
      and prevent obesity. A more recent study has found that T2DM was inversely correlated with
      osteocalcin levels . There is a strong correlation between OSC and fibroblastic factor -23
      (FBF-23). Many recent studies have correlated FBF-23 as well as vitamin D levels with some of
      the pathological conditions such as chronic kidney failure, atherosclerosis, and diabetes.
      They stated possible interrelationships between insulin resistance, Hyperinsulinemia, and/or
      lower VD3 levels may lead to decreased serum FGF-23 concentrations in obese children and
      adolescents. Therefore, serum FGF-23 has been suggested to be a potential indicator of
      subclinical atherosclerosis in patients with gestational diabetes mellitus. Based on these
      data, we expect that a high dose of vitamin D will significantly influence the association
      between A1c with FGF-23 levels in people with vitamin D deficiency.
    

Intervention name(s): Soft gelatin capsules each contains 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.
Intervention type(s): Dietary Supplement
Intervention description(s): Soft gelatin capsules each contain 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention