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

Primary Purpose

Diabetes Mellitus, Type 2, Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Soft gelatin capsules each contains 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.
Sponsored by
Applied Science Private University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

22 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Inclusion criteria included males and females in the age range of 22-55 years with a medical diagnosis of vitamin D deficiency.

Exclusion Criteria:

  • subjects with any chronic disease such as kidney failure, CVD, diabetes, blood disorders, or immune problems, including autoimmune diseases, chronic or severe infections will be excluded.

Sites / Locations

  • Mahmoud S Abu-Samak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VD3 group

Control group

Arm Description

Dietary Supplement: Soft gelatin capsules each contain 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg once weekly for 8 weeks. .

none has been administered

Outcomes

Primary Outcome Measures

FGF-23
plasma levels
A1c
plasma percentage

Secondary Outcome Measures

Osteocalcin
plasma levels
25OHD
serum

Full Information

First Posted
December 19, 2020
Last Updated
February 23, 2022
Sponsor
Applied Science Private University
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1. Study Identification

Unique Protocol Identification Number
NCT04682626
Brief Title
Effect of Weekly High-dose Vitamin D3 Supplementation on the Association Between Circulatory FGF-23 and A1c Levels
Official Title
Effect of Weekly High-dose Vitamin D3 Supplementation on the Association Between Circulatory FGF-23 and A1c Levels in People With Vitamin D Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 25, 2020 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Applied Science Private University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Kidney Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VD3 group
Arm Type
Experimental
Arm Description
Dietary Supplement: Soft gelatin capsules each contain 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg once weekly for 8 weeks. .
Arm Title
Control group
Arm Type
No Intervention
Arm Description
none has been administered
Intervention Type
Dietary Supplement
Intervention Name(s)
Soft gelatin capsules each contains 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.
Intervention Description
Soft gelatin capsules each contain 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.
Primary Outcome Measure Information:
Title
FGF-23
Description
plasma levels
Time Frame
10 weeks
Title
A1c
Description
plasma percentage
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Osteocalcin
Description
plasma levels
Time Frame
10 weeks
Title
25OHD
Description
serum
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria included males and females in the age range of 22-55 years with a medical diagnosis of vitamin D deficiency. Exclusion Criteria: subjects with any chronic disease such as kidney failure, CVD, diabetes, blood disorders, or immune problems, including autoimmune diseases, chronic or severe infections will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abu-Samak, PhD
Organizational Affiliation
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sara Al-imam, MSc
Organizational Affiliation
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahmoud S Abu-Samak
City
Amman
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31303782
Citation
Abu-Samak MS, AbuRuz ME, Masa'Deh R, Khuzai R, Jarrah S. Correlation of selected stress associated factors with vitamin D deficiency in Jordanian men and women. Int J Gen Med. 2019 Jun 28;12:225-233. doi: 10.2147/IJGM.S198175. eCollection 2019.
Results Reference
result
PubMed Identifier
30787641
Citation
Al-Shaer AH, Abu-Samak MS, Hasoun LZ, Mohammad BA, Basheti IA. Assessing the effect of omega-3 fatty acid combined with vitamin D3 versus vitamin D3 alone on estradiol levels: a randomized, placebo-controlled trial in females with vitamin D deficiency. Clin Pharmacol. 2019 Feb 4;11:25-37. doi: 10.2147/CPAA.S182927. eCollection 2019.
Results Reference
result
PubMed Identifier
20714685
Citation
Abu-Hasheesh MO, Abu-Samak MS, Al-Matubsi HY, Jaradeh MS, Jarrah SS, Khuzaie RF. Association of parental history of type 2 diabetes mellitus with leptin levels in Jordanian male youths. Saudi Med J. 2010 Aug;31(8):882-6.
Results Reference
result
PubMed Identifier
31819593
Citation
Abu-Taha M, Dagash R, Mohammad BA, Basheiti I, Abu-Samak MS. Combined Effect Of Coffee Consumption And Cigarette Smoking On Serum Levels Of Vitamin B12, Folic Acid, And Lipid Profile In Young Male: A Cross-Sectional Study. Int J Gen Med. 2019 Nov 22;12:421-432. doi: 10.2147/IJGM.S213737. eCollection 2019. Erratum In: Int J Gen Med. 2020 Feb 04;13:27.
Results Reference
result

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

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