Effect of Vitamin d and Omega 3 on Osteocalcin

Study Overview
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Brief Summary
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Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin levels

Detailed Description
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The data about effect of vitamin D3 (VD3) and omega-3 fatty acids(omega-3FA) on plasma levels of osteocalcin (OCN) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the OCN levels. This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on PLASMA OCN levels in females and males with vitamin D deficiency (VDD). This randomized, controlled clinical trial was designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks,separately and with each other, on the plasma levels of OCN and 25-hydroxy vitamin D (25OHD). This study was conducted during winter in 86 healthy Jordanian females and males with VDD with a mean age of (40± 10) years. Fasting serum levels for 25OHD,OCN, PTH (parathyroid hormone),calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial .

Official Title
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Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Plasma Osteocalcin Levels : a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: vitamin D3
* Dietary Supplement: omega-3 fatty acid
* Dietary Supplement: vitamin D3 and omega-3 fatty acid
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical diagnosis of vitamin D deficiency (VD < 30 ng / ml). Exclusion Criteria: People who previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation. People with bone disorders also excluded.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 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 group<br>weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks | Dietary Supplement: vitamin D3<br>* 50,000 IU VD3 / week for 8 weeks<br>Dietary Supplement: omega-3 fatty acid<br>* 300 mg of omega 3-FA once daily for 8 weeks<br>Dietary Supplement: vitamin D3 and omega-3 fatty acid<br>* 50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks<br>Other: control<br>* no intervention<br>|
| Experimental: omega3-Fatty Acid group<br>1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily | Dietary Supplement: vitamin D3<br>* 50,000 IU VD3 / week for 8 weeks<br>Dietary Supplement: omega-3 fatty acid<br>* 300 mg of omega 3-FA once daily for 8 weeks<br>Dietary Supplement: vitamin D3 and omega-3 fatty acid<br>* 50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks<br>Other: control<br>* no intervention<br>|
| Experimental: VD3 and Omega-3FA group<br>50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily | Dietary Supplement: vitamin D3<br>* 50,000 IU VD3 / week for 8 weeks<br>Dietary Supplement: omega-3 fatty acid<br>* 300 mg of omega 3-FA once daily for 8 weeks<br>Dietary Supplement: vitamin D3 and omega-3 fatty acid<br>* 50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks<br>Other: control<br>* no intervention<br>|
| No Intervention: Control group<br>NO INTERVENTION | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin d3 levels | Plasma levels of 25-hydroxyvitamin D | 8 weeks | 
| osteocalcin levels | plasma osteocalcin levels | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTH | Plasma concentrations of PTH | 8 weeks | 
| calcium | plasma Ca levels | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D Deficiency, plama osteocalcin, omega-3 fatty acids