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NCT03735303 Clinical Trial

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

Vitamin D Deficiency Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03735303
Other study ID # DRGS-4-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date June 1, 2019

Study information
Verified date December 2018
Source Applied Science Private University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility
Status Completed
Enrollment 146
Est. completion date June 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• VD3 group
VD3 50000 IU/ week for 8 weeks
• omega 3 FA group
omega 3 FA group 300 mg once daily for 8 weeks
• VD3 and omega- 3FA group
50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks
Other:
• control group
no intervention was given

Locations
Country Name City State
Jordan Applied Science University Amman

Sponsors (1)
Lead Sponsor Collaborator
Applied Science Private University

Country where clinical trial is conducted

Jordan, 

References & Publications (1)

Ross AC. The 2011 report on dietary reference intakes for calcium and vitamin D. Public Health Nutr. 2011 May;14(5):938-9. doi: 10.1017/S1368980011000565. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary VD 3 Serum level of 25-hydroxyvitamin D 8 weeks
Primary leptin serum level of leptin 8 weeks
Primary HbA1C plasma concentration of HbA1C 8 weeks
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