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

NCT ID: NCT04682626

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-25
• Study Completion Date: 2021-03-20

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.

Conditions

Diabetes Mellitus, Type 2; Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

VD3 group

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

.

Group Type: EXPERIMENTAL

Soft gelatin capsules each contains 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.

Intervention Type: DIETARY_SUPPLEMENT

Soft gelatin capsules each contain 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.

Control group

none has been administered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Applied Science Private University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Suleiman Abu-Samak

Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud S Abu-Samak, PhD

Role: STUDY_CHAIR

Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan

Sara Al-imam, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan

Locations

Mahmoud S Abu-Samak

Amman, , Jordan

Countries

Jordan

References

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.

Reference Type: RESULT

PMID: 31303782 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30787641 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20714685 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31819593 (View on PubMed)

Other Identifiers

2020-PHA-23

Identifier Type: -

Identifier Source: org_study_id