The Effects of Vitamin D3 Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control
The Effects of Vitamin D3 Supplementation Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control; A Randomized Controlled Trial in People With Vitamin D Deficiency
1 other identifier
interventional
115
1 country
1
Brief Summary
The Effects of Vitamin D3 alone and in a combination with omega-3 on the association of C-peptide with glycemic control
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2020
CompletedFirst Submitted
Initial submission to the registry
March 11, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJuly 14, 2020
July 1, 2020
3 months
March 11, 2020
July 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C
Concentration
8 weeks
Secondary Outcomes (1)
Plasma Concentration of PTH and Calcium
8 weeks
Study Arms (4)
Vitamin D3 alone Group
EXPERIMENTALTreated with VD3 (50.000 IU/week)
Omaga-3 alone Group
EXPERIMENTALTreated with (1000 mg) wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily.
Vitamin D3 and Omega-3 Combination, Group
EXPERIMENTALTreated with 50.000 IU VD3 per week and 1000 mg wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily.
Control Group
EXPERIMENTALNo intervention was given.
Interventions
VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks
Eligibility Criteria
You may qualify if:
- Aged (30-64)
- Have a medical diagnosis of VDD
You may not qualify if:
- Chronic diseases, such as (osteoporosis, cancer, kidney disease(due to the association between prolonged administration of VD3 and kidney stones formation), an endocrine disorder, thalassemia).
- Documented history of allergic reactions to Omega-3FA supplementations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Applied Science University
Amman, Jordan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud S Abu-samak, PhD
Applied Science Private University (ASU)
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
March 11, 2020
First Posted
March 13, 2020
Study Start
March 10, 2020
Primary Completion
June 10, 2020
Study Completion
June 30, 2020
Last Updated
July 14, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- When summary data are published
- Access Criteria
- Open access
All IPD that underline results in a publication.