The Effects of Vitamin D3 Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control

Study Overview
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Brief Summary
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The Effects of Vitamin D3 alone and in a combination with omega-3 on the association of C-peptide with glycemic control

Detailed Description
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The data bout the effects of Vitamin D3 (VD3) alone and as a combination with omega-3 fatty acids (Omega-3FA) on the association between C-peptide (CP) and the glycated hemoglobin (HbA1c) is scarce, conflicting and nothing published in the literature review on the combined effect of VD3 and Omega-3FA as a combination on the association of CP with glycemic control. This study will be conducted to investigate the effects of (VD3) alone and as a combination with Omega-3FA on the association between CP as an insulin secretion marker, and glycemic control parameters represented by glycated Hemoglobin (HbA1c), on people with vitamin D deficiency (VDD). This randomized, placebo-controlled trial is designed to test the effects of (50,000 IU VD3/ weekly) and (300mg omega-3FA/daily) separately and as a combination for eight weeks, on the serum levels of CP, 25-hydroxy vitamin D (25OHD) and HbA1c. this study will be carried out during winter on 120 healthy Jordanian males and females with VDD with age range (25-50) years. Fasting serum levels for 25OHD, CP, HbA1c, PTH, Calcium, Phosphate, ALT (Alanine aminotransferase) and Urea were assessed at baseline and at the end of the trial.

Official Title
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The Effects of Vitamin D3 Supplementation Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control; A Randomized Controlled Trial in People With Vitamin D Deficiency

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: VD3
* Dietary Supplement: Omega-3FA
* Dietary Supplement: VD3 and Omega-3FA
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged (30-64) Have a medical diagnosis of VDD Exclusion Criteria: Chronic diseases, such as (osteoporosis, cancer, kidney disease(due to the association between prolonged administration of VD3 and kidney stones formation), an endocrine disorder, thalassemia). Documented history of allergic reactions to Omega-3FA supplementations

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 64 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 alone Group<br>Treated with VD3 (50.000 IU/week) | Dietary Supplement: VD3<br>* VD3 (50.000 IU/week) for 8 weeks<br>|
| Experimental: Omaga-3 alone Group<br>Treated with (1000 mg) wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily. | Dietary Supplement: Omega-3FA<br>* Omaga-3FA (300 mg/day) for 8 weeks<br>|
| Experimental: Vitamin D3 and Omega-3 Combination, Group<br>Treated with 50.000 IU VD3 per week and 1000 mg wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily. | Dietary Supplement: VD3 and Omega-3FA<br>* VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks<br>|
| Experimental: Control Group<br>No intervention was given. | Other: Control<br>* No intervention is given<br>* Other names: nothing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C | Concentration | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of PTH and Calcium | Concentration | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VD3, Vitamin D Deficiency, vitamin D3, omega-3 fatty acids, glycated Hemoglubine, C-peptide, Insulin resistance, A1C, HbA1C