Vitamin D DeficiencyNCT05916053
Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults
A study testing Vitamin D supplementation in people with Vitamin D Deficiency and Depressive Symptoms, run by Lebanese American University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Depressive Symptoms
- What is being tested?
- Vitamin D supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Three-Months Vitamin D 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:
Read more
- 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
- Being tested
- Vitamin D supplementation
- Medical subject headings
- Vitamin D Deficiency, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementationDietary supplement
50.000 IU of vitamin D supplementation was prescribed for deficient/insufficient participants for a 3 month period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Sep 2021
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lebanese American University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rashel S. Khaddaj, Lebanese American University
- Investigators
- Berna Rahi, PHD, Study director, Sam Houston State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916053
- Sponsor's protocol ID
- LAU.SAS.BR2.12/Sep/2021
- Status last verified
- Jul 2023
- First submitted
- 14 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Three-Months Vitamin D Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults
- ClinicalTrials.gov ID
- NCT05916053
- Acronym / sponsor ID
- LAU.SAS.BR2.12/Sep/2021
- Conditions
- Vitamin D Deficiency, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Lebanese American UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Nutritional education about food sources of vitamin D |
| VItamin D supplemented | Experimental | Dietary Supplement: Vitamin D supplementationVitamin D supplementation of 50.000 IU weekly for 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D supplementation50.000 IU of vitamin D supplementation was prescribed for deficient/insufficient participants for a 3 month period. | Dietary supplement | VItamin D supplemented |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berna Rahi, PHD study director
Sam Houston State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D supplementation in people with Vitamin D Deficiency and Depressive Symptoms, run by Lebanese American University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptomatology (time frame: 3 months supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.