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

NCT04682626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-03-09

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Applied Science Private University

    lead OTHER

Principal Investigators

  • Mahmoud S Abu-Samak, PhD · Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan

  • Sara Al-imam, MSc · Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-25
Primary Completion
2021-03-05
Completion
2021-03-20

Countries

  • Jordan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04682626 on ClinicalTrials.gov