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

Study Overview
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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 .

Official Title
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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.

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: VD3 group
* Dietary Supplement: omega 3 FA group
* Dietary Supplement: VD3 and omega- 3FA group
* Other: control group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VD3 group<br>dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks | Dietary Supplement: VD3 group<br>* VD3 50000 IU/ week for 8 weeks<br>|
| Experimental: omega 3- FA group<br>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 | Dietary Supplement: omega 3 FA group<br>* omega 3 FA group 300 mg once daily for 8 weeks<br>|
| Experimental: VD3 and omega 3 FA group<br>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 | Dietary Supplement: VD3 and omega- 3FA group<br>* 50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks<br>|
| Experimental: control group<br>no intervention was given | Other: control group<br>* no intervention was given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VD 3 | Serum level of 25-hydroxyvitamin D | 8 weeks | 
| leptin | serum level of leptin | 8 weeks | 
| HbA1C | plasma concentration of HbA1C | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D3, vitamin D deficiency, leptin, A1C, omega-3 fatty acid