NCT04005612

Effect of Vitamin d and Omega 3 on Osteocalcin

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Applied Science Private University · Academic / Other
• Sex: All
• Age: 22 Years – 50 Years
• Healthy volunteers: Accepted

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 .

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin D3	50,000 IU VD3 / week for 8 weeks
DIETARY_SUPPLEMENT	omega-3 fatty acid	300 mg of omega 3-FA once daily for 8 weeks
DIETARY_SUPPLEMENT	vitamin D3 and omega-3 fatty acid	50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
OTHER	control	no intervention

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2019-07-02
• Last updated: 2020-07-14

Locations

1 site across 1 country: Jordan