Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults

Sponsor

Lebanese American University (Other)

Overall Status

Completed

CT.gov ID

NCT05916053

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

11.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency Depressive Symptoms	Dietary Supplement: Vitamin D supplementation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Nutritional education about food sources of vitamin D
Experimental: VItamin D supplemented Vitamin D supplementation of 50.000 IU weekly for 3 months.	Dietary Supplement: Vitamin D supplementation 50.000 IU of vitamin D supplementation was prescribed for deficient/insufficient participants for a 3 month period.

Arm

Intervention/Treatment

No Intervention: Control

Nutritional education about food sources of vitamin D

Experimental: VItamin D supplemented

Vitamin D supplementation of 50.000 IU weekly for 3 months.

Dietary Supplement: Vitamin D supplementation

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

Outcome Measures

Primary Outcome Measures

Depressive symptomatology [3 months supplementation]
Assess depressive symptomatology via Patient Health Questionnaire-9

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Themal Medical Center	Abha		Saudi Arabia

Sponsors and Collaborators

Lebanese American University

Investigators

Study Director: Berna Rahi, PHD, Sam Houston State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rashel S. Khaddaj, MS Student, Lebanese American University

ClinicalTrials.gov Identifier:

NCT05916053

Other Study ID Numbers:

LAU.SAS.BR2.12/Sep/2021

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vitamin D Deficiency

Depression

Vitamin D

Study Results

No Results Posted as of Jun 23, 2023