Effect of Vitamin d and Omega 3 on Osteocalcin

Applied Science Private University

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Other: control; Dietary Supplement: omega-3 fatty acid; Dietary Supplement: vitamin D3 and omega-3 fatty acid; Dietary Supplement: vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT04005612

DRGS-2014-2015-165-3

Details and patient eligibility

About

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

Full 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 .

Enrollment: 120 patients

Sex: All

Ages: 22 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 4 patient groups

vitamin d3 group

Experimental group

Description:

weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks

Treatment:

Dietary Supplement: omega-3 fatty acid

Dietary Supplement: vitamin D3 and omega-3 fatty acid

Dietary Supplement: vitamin D3

Other: control

omega3-Fatty Acid group

Experimental group

Description:

1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily

Treatment:

Dietary Supplement: omega-3 fatty acid

Dietary Supplement: vitamin D3 and omega-3 fatty acid

Dietary Supplement: vitamin D3

Other: control

VD3 and Omega-3FA group

Experimental group

Description:

50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily

Treatment:

Dietary Supplement: omega-3 fatty acid

Dietary Supplement: vitamin D3 and omega-3 fatty acid

Dietary Supplement: vitamin D3

Other: control

Control group

No Intervention group

Description:

NO INTERVENTION