Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults
NCT ID: NCT05916053
Last Updated: 2023-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2021-09-01
2022-03-01
Brief Summary
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The main questions it aims to answer are:
* Is Vitamin D deficiency associated with an increased prevalence of depressive symptomatology among Saudi Arabian Population?
* Is Vitamin D Supplementation for a period of 3-month at 50,000 International Units might be associated with an improved depressive status? All the participants were clients who attended the clinic to help with weight management - who were doing regular medical check-ups - at Al Themal Medical Center which is located in Abha, Saudi Arabia.
Participants were requested to do a general blood test to check for any vitamins and minerals deficiencies as part of the routine clinical procedure. This procedure did not incur any additional costs on the behalf of the participants. The participants who were identified to have any deficiencies were recommended to take supplements, also as part of the routine clinical procedure. Therefore, participants identified to be deficient or insufficient Vitamin D levels were screened and recruited to participate in the current study.
Participants were randomly assigned to either an interventional (vitamin D) or placebo group (control). The interventional group received vitamin D supplementation of 50.000International Units/week for 3 months and the placebo group received dietary advice and education on food sources of vitamin D for the same period. Both Groups received a weight gain or a weight loss diet as per their case.
At the three-months follow-up, the participants were readministered the face-to-face questionnaire and their blood levels for vitamin D were also checked.
Thus, this study would add value to the actions taken to treat vitamin D deficiency in Saudi Arabian adults. This might also assist in approaching new recommendations related to preventing or treating depression via vitamin D supplementation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
Nutritional education about food sources of vitamin D
No interventions assigned to this group
VItamin D supplemented
Vitamin D supplementation of 50.000 IU weekly for 3 months.
Vitamin D supplementation
50.000 IU of vitamin D supplementation was prescribed for deficient/insufficient participants for a 3 month period.
Interventions
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Vitamin D supplementation
50.000 IU of vitamin D supplementation was prescribed for deficient/insufficient participants for a 3 month period.
Eligibility Criteria
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Inclusion Criteria
* Be Vitamin D deficient/Insufficient (As tested via blood levels)
* Have a BMI between 17kg/m2 \& 55 kg/m2
* Able to understand Arabic
* Able to provide written consent
Exclusion Criteria
* Participants having normal vitamin D levels
* Participants reporting other mental health diseases
* Pregnant or lactating women.
18 Years
65 Years
ALL
Yes
Sponsors
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Lebanese American University
OTHER
Responsible Party
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Rashel S. Khaddaj
Principal Investigator
Principal Investigators
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Berna Rahi, PHD
Role: STUDY_DIRECTOR
Sam Houston State University
Locations
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Al Themal Medical Center
Abhā, , Saudi Arabia
Countries
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Other Identifiers
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LAU.SAS.BR2.12/Sep/2021
Identifier Type: -
Identifier Source: org_study_id
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