Effect of Vitamin d and Omega 3 on Osteocalcin
- Conditions
- Vitamin D Deficiency
- Interventions
- Dietary Supplement: vitamin D3Dietary Supplement: omega-3 fatty acidDietary Supplement: vitamin D3 and omega-3 fatty acidOther: control
- Registration Number
- NCT04005612
- Lead Sponsor
- Applied Science Private University
- Brief Summary
Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin levels
- Detailed Description
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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Medical diagnosis of vitamin D deficiency (VD < 30 ng / ml).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vitamin d3 group control weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks vitamin d3 group vitamin D3 weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks omega3-Fatty Acid group omega-3 fatty acid 1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily omega3-Fatty Acid group vitamin D3 and omega-3 fatty acid 1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily VD3 and Omega-3FA group control 50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily vitamin d3 group omega-3 fatty acid weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks vitamin d3 group vitamin D3 and omega-3 fatty acid weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks omega3-Fatty Acid group vitamin D3 1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily omega3-Fatty Acid group control 1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily VD3 and Omega-3FA group vitamin D3 and omega-3 fatty acid 50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily VD3 and Omega-3FA group vitamin D3 50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily VD3 and Omega-3FA group omega-3 fatty acid 50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily
- Primary Outcome Measures
Name Time Method vitamin d3 levels 8 weeks Plasma levels of 25-hydroxyvitamin D
osteocalcin levels 8 weeks plasma osteocalcin levels
- Secondary Outcome Measures
Name Time Method PTH 8 weeks Plasma concentrations of PTH
calcium 8 weeks plasma Ca levels
Trial Locations
- Locations (1)
Applied Science University
🇯🇴Amman, Jordan