Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults

NCT05916053 | Completed DMC

• 1 other identifier: LAU.SAS.BR2.12/Sep/2021
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months supplementation

Study Arms (2)

Control

NO INTERVENTION

Nutritional education about food sources of vitamin D

VItamin D supplemented

EXPERIMENTAL

Vitamin D supplementation of 50.000 IU weekly for 3 months.

Dietary Supplement: Vitamin D supplementation

Interventions

Vitamin D supplementation DIETARY_SUPPLEMENT

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

VItamin D supplemented

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lebanese American University: lead

Study Sites (1)

Al Themal Medical Center

Abhā, Saudi Arabia

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Depression

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Study Officials

• Berna Rahi, PHD

  Sam Houston State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: September 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)