NCT03735303

Brief Summary

The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

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

November 7, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 17, 2019

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

November 7, 2018

Last Update Submit

July 16, 2019

Conditions

Vitamin D Deficiency

Keywords

vitamin D3vitamin D deficiencyleptinA1Comega-3 fatty acid

Outcome Measures

Primary Outcomes (3)

  • VD 3

    Serum level of 25-hydroxyvitamin D

    8 weeks

  • leptin

    serum level of leptin

    8 weeks

  • HbA1C

    plasma concentration of HbA1C

    8 weeks

Study Arms (4)

VD3 group

EXPERIMENTAL

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

Dietary Supplement: VD3 group

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 group

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 group

control group

EXPERIMENTAL

no intervention was given

Other: control group

Interventions

VD3 groupDIETARY_SUPPLEMENT

VD3 50000 IU/ week for 8 weeks

VD3 group
omega 3 FA groupDIETARY_SUPPLEMENT

omega 3 FA group 300 mg once daily for 8 weeks

omega 3- FA group
VD3 and omega- 3FA groupDIETARY_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
control groupOTHER

no intervention was given

control group

Eligibility Criteria

Age25 Years - 55 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:

  • Blood disorders including
  • thalassemia
  • sickle cell disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Science University

Amman, 11931, Jordan

Location

Related Publications (1)

  • Ross AC. The 2011 report on dietary reference intakes for calcium and vitamin D. Public Health Nutr. 2011 May;14(5):938-9. doi: 10.1017/S1368980011000565. No abstract available.

    PMID: 21492489RESULT

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Control Groups

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Mahmoud S Abu-Samak, PhD

    Applied Science Private University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 8, 2018

Study Start

December 1, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

July 17, 2019

Record last verified: 2018-12

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)