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Effect of Vitamin d and Omega 3 on Osteocalcin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005612
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Applied Science Private University

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

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: vitamin D3 Dietary Supplement: omega-3 fatty acid Dietary Supplement: vitamin D3 and omega-3 fatty acid Other: control Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vitamin d3 group
weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks
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

Experimental: omega3-Fatty Acid group
1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily
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

Experimental: VD3 and Omega-3FA group
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
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

No Intervention: Control group
NO INTERVENTION



Primary Outcome Measures :
  1. vitamin d3 levels [ Time Frame: 8 weeks ]
    Plasma levels of 25-hydroxyvitamin D

  2. osteocalcin levels [ Time Frame: 8 weeks ]
    plasma osteocalcin levels


Secondary Outcome Measures :
  1. PTH [ Time Frame: 8 weeks ]
    Plasma concentrations of PTH

  2. calcium [ Time Frame: 8 weeks ]
    plasma Ca levels



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Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005612


Locations
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Jordan
Applied Science University
Amman, Jordan
Sponsors and Collaborators
Applied Science Private University
Investigators
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Principal Investigator: Mahmoud S Abu-Samak, PhD Applied Science Private University
Publications:
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Responsible Party: Applied Science Private University
ClinicalTrials.gov Identifier: NCT04005612    
Other Study ID Numbers: DRGS-2014-2015-165-3
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: when summary data are published
Access Criteria: open access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Applied Science Private University:
Vitamin D Deficiency
plama osteocalcin
omega-3 fatty acids
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents