Effect of Vitamin d and Omega 3 on Osteocalcin
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
1 other identifier
interventional
120
1 country
1
Brief Summary
Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin levels
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 Nov 2019
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
First Submitted
Initial submission to the registry
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 2, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedJuly 14, 2020
July 1, 2020
3 months
July 1, 2019
July 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
vitamin d3 levels
Plasma levels of 25-hydroxyvitamin D
8 weeks
osteocalcin levels
plasma osteocalcin levels
8 weeks
Secondary Outcomes (2)
PTH
8 weeks
calcium
8 weeks
Study Arms (4)
vitamin d3 group
EXPERIMENTALweekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks
omega3-Fatty Acid group
EXPERIMENTAL1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily
VD3 and Omega-3FA group
EXPERIMENTAL50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily
Control group
NO INTERVENTIONNO INTERVENTION
Interventions
50,000 IU VD3 / week for 8 weeks
300 mg of omega 3-FA once daily for 8 weeks
50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
Eligibility Criteria
You may qualify if:
- Medical diagnosis of vitamin D deficiency (VD \< 30 ng / ml).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Applied Science University
Amman, Jordan
Related Publications (1)
Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
PMID: 18400738BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud S Abu-Samak, PhD
Applied Science Private University
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
November 1, 2019
Primary Completion
February 1, 2020
Study Completion
February 1, 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 underlie results in a publication