Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Behavior Behavioral Symptoms Deficiency Diseases Depression Depressive Symptoms Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Themal Medical Center

Abhā, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D Supplementation

Dietary Supplement

50.000 IU of vitamin D supplementation was prescribed for deficient/insufficient participants for a 3 month period.

Primary outcomes

Depressive symptomatology

Time frame: 3 months supplementation

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.

Sponsors and collaborators

Lead sponsor

Lebanese American University

Other

Registry information

Official study title

Association Between Three-Months Vitamin D Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 23, 2023
Registry last updated: Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed