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

NCT04682626 | Completed DMC

• 1 other identifier: 2020-PHA-23
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• FGF-23

  plasma levels

  10 weeks

• A1c

  plasma percentage

  10 weeks

Secondary Outcomes (2)

• Osteocalcin

  10 weeks

• 25OHD

  10 weeks

Study Arms (2)

VD3 group

EXPERIMENTAL

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

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

Control group

NO INTERVENTION

none has been administered

Interventions

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

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

VD3 group

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Applied Science Private University: lead

Study Sites (1)

Mahmoud S Abu-Samak

Amman, Jordan

Location

Related Publications (4)

• 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.

  PMID: 31303782 RESULT

• 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.

  PMID: 30787641 RESULT

• 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.

  PMID: 20714685 RESULT

• 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.

  PMID: 31819593 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Kidney Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Mahmoud S Abu-Samak, PhD

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

  STUDY CHAIR

• Sara Al-imam, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 24, 2020
• Study Start: December 25, 2020
• Primary Completion: March 5, 2021
• Study Completion: March 20, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)