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Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults

Primary Purpose

Vitamin D Deficiency, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Vitamin D supplementation
Sponsored by
Lebanese American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Males and females Aged between 18 and 65 years old 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 already taking Vitamin D supplements or Anti-depressants Participants having normal vitamin D levels Participants reporting other mental health diseases Pregnant or lactating women.

Sites / Locations

  • Al Themal Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

VItamin D supplemented

Arm Description

Nutritional education about food sources of vitamin D

Vitamin D supplementation of 50.000 IU weekly for 3 months.

Outcomes

Primary Outcome Measures

Depressive symptomatology
Assess depressive symptomatology via Patient Health Questionnaire-9. The lower the score, the better the outcome. The scores of the Patient Health Questionnaire-9 were interpreted as follows: 0-4 Minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
July 6, 2023
Sponsor
Lebanese American University
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1. Study Identification

Unique Protocol Identification Number
NCT05916053
Brief Title
Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults
Official Title
Association Between Three-Months Vitamin D Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lebanese American University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this randomized controlled trial is to explore the relationship between Vitamin D supplementation and depressive symptomatology in Saudi Arabian Population. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Depressive Symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Nutritional education about food sources of vitamin D
Arm Title
VItamin D supplemented
Arm Type
Experimental
Arm Description
Vitamin D supplementation of 50.000 IU weekly for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplementation
Intervention Description
50.000 IU of vitamin D supplementation was prescribed for deficient/insufficient participants for a 3 month period.
Primary Outcome Measure Information:
Title
Depressive symptomatology
Description
Assess depressive symptomatology via Patient Health Questionnaire-9. The lower the score, the better the outcome. The scores of the Patient Health Questionnaire-9 were interpreted as follows: 0-4 Minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.
Time Frame
3 months supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females Aged between 18 and 65 years old 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 already taking Vitamin D supplements or Anti-depressants Participants having normal vitamin D levels Participants reporting other mental health diseases Pregnant or lactating women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berna Rahi, PHD
Organizational Affiliation
Sam Houston State University
Official's Role
Study Director
Facility Information:
Facility Name
Al Themal Medical Center
City
Abha
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults

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