NCT04682626

Effect of Weekly High-dose Vitamin D3 Supplementation on the Association Between Circulatory FGF-23 and A1c Levels

Effect of Weekly High-dose Vitamin D3 Supplementation on the Association Between Circulatory FGF-23 and A1c Levels in People With Vitamin D Deficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Applied Science Private University · Academic / Other
• Sex: All
• Age: 22 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Kidney Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Soft gelatin capsules each contains 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.	Soft gelatin capsules each contain 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.

Timeline

• Start date: 2020-12-25
• Primary completion: 2021-03-05
• Completion: 2021-03-20
• First posted: 2020-12-24
• Last updated: 2022-03-09

Locations

1 site across 1 country: Jordan