Effect of Vitamin D3 and Omega-3FA on Leptin and HbA1C With Vitamin D Deficiency

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: omega 3 FA group; Dietary Supplement: VD3 and omega- 3FA group; Other: control group; Dietary Supplement: VD3 group

• Registration Number: NCT03735303
• Lead Sponsor: Applied Science Private University

Brief Summary

The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

Detailed Description

Nothing is published in the literature about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum leptin and glycated hemoglobin ( HbA1C)

This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 1000 mg omega-3FA daily for eight weeks, separately and with each other, on on serum leptin and Glycated hemoglobin (Hb A1C) levels .

Study Timeline

• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-08
• Status Verified: 2018-12
• Study Start: 2018-12-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-01
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• jordanian people aged 25-55
• medical diagnosis of vitamin D deficiency ( VD <25 ng/ ml)

Exclusion Criteria

• Blood disorders including
• thalassemia
• sickle cell disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
omega 3- FA group	omega 3 FA group	dietary supplement : omega 3- FA group 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks
VD3 and omega 3 FA group	VD3 and omega- 3FA group	dietary supplement : VD3 and omega-3FA 50000 IU VD3/week for 8 weeks and 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks
control group	control group	no intervention was given
VD3 group	VD3 group	dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks

Primary Outcome Measures

Name	Time	Method
HbA1C	8 weeks	plasma concentration of HbA1C
leptin	8 weeks	serum level of leptin
VD 3	8 weeks	Serum level of 25-hydroxyvitamin D

Trial Locations

Locations (1)

Applied Science University; 🇯🇴 Amman, Jordan