NCT04005573

Brief Summary

The combined effect of omega-3 fatty acid and vitamin D3 on lipid profile levels and oxidized low density lipoprotein: a randomized controlled trial in males and females with vitamin D deficiency

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

July 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 13, 2020

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 1, 2019

Last Update Submit

January 10, 2020

Conditions

Vitamin D Deficiency

Keywords

vitamin D3Vitamin D DeficiencyLipid profileoxidized low density Lipoproteinomega-3 fatty acids

Outcome Measures

Primary Outcomes (6)

  • VD 3

    Serum level of 25-hydroxyvitamin D

    8 weeks

  • Total Cholesterol

    serum level of total cholesterol

    8 weeks

  • HDL Cholesterol

    serum level of HDL Cholesterol

    8 weeks

  • LDL Cholesterol

    serum level of LDL Cholesterol

    8 weeks

  • triglycerides

    serum level of triglycerides

    8 weeks

  • oxidized LDL

    serum level of oxidized LDL

    8 weeks

Secondary Outcomes (2)

  • PTH

    8 weeks

  • Calcium and Phosphorus

    8 weeks

Study Arms (4)

VD3 group

EXPERIMENTAL

dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks

Dietary Supplement: VD3

omega 3- FA group

EXPERIMENTAL

dietary supplement : omega 3- FA group 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks

Dietary Supplement: omega 3- FA

VD3 and omega 3 FA group

EXPERIMENTAL

dietary supplement : VD3 and omega-3FA 50000 IU VD3/week for 8 weeks and 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks

Dietary Supplement: VD3 and omega- 3FA

control group

OTHER

no intervention was given

Other: no intervention

Interventions

VD3DIETARY_SUPPLEMENT

VD3 50000 IU/ week for 8 weeks

VD3 group
omega 3- FADIETARY_SUPPLEMENT

Omega 3 FA group 300 mg once daily for 8 weeks

omega 3- FA group
VD3 and omega- 3FADIETARY_SUPPLEMENT

50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks

VD3 and omega 3 FA group
no interventionOTHER

no intervention is given

control group

Eligibility Criteria

Age22 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Jordanian people aged 25-55 medical diagnosis of vitamin D deficiency ( VD \<25 ng/ ml)

You may not qualify if:

  • Subjects with previously diagnosed with any chronic disease (cardiovascular disease, osteoporosis, cancer, kidney disease, endocrine disorder, thalassemia) or has a documented history of allergic reactions to n-3FA supplementations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Science University

Amman, Jordan

Location

Related Publications (1)

  • Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.

    PMID: 21986389BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Mahmoud S Abu-Samak, PhD

    Applied science university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 2, 2019

Study Start

July 10, 2019

Primary Completion

November 1, 2019

Study Completion

January 1, 2020

Last Updated

January 13, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

all IPD that underline results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
when summary data will published
Access Criteria
open access

Locations

JO(1)