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

NCT ID: NCT03735303

Last Updated: 2019-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-06-01

Brief Summary

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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

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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 .

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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VD3 group

dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks

Group Type EXPERIMENTAL

VD3 group

Intervention Type DIETARY_SUPPLEMENT

VD3 50000 IU/ week for 8 weeks

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

Group Type EXPERIMENTAL

omega 3 FA group

Intervention Type DIETARY_SUPPLEMENT

omega 3 FA group 300 mg once daily for 8 weeks

VD3 and omega 3 FA 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

Group Type EXPERIMENTAL

VD3 and omega- 3FA group

Intervention Type DIETARY_SUPPLEMENT

50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks

control group

no intervention was given

Group Type EXPERIMENTAL

control group

Intervention Type OTHER

no intervention was given

Interventions

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VD3 group

VD3 50000 IU/ week for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

omega 3 FA group

omega 3 FA group 300 mg once daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

VD3 and omega- 3FA group

50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

control group

no intervention was given

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Applied Science Private University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud S Abu-Samak, PhD

Role: PRINCIPAL_INVESTIGATOR

Applied Science Private University

Locations

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Applied Science University

Amman, , Jordan

Site Status

Countries

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Jordan

References

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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. No abstract available.

Reference Type RESULT
PMID: 21492489 (View on PubMed)

Other Identifiers

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DRGS-4-2018

Identifier Type: -

Identifier Source: org_study_id

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