Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000525583
Ethics application status
Approved
Date submitted
30/12/2023
Date registered
27/04/2024
Date last updated
27/04/2024
Date data sharing statement initially provided
27/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of ascorbic acid in the expression of miRNA and mood in patients with depression: A randomized controlled trial.
Scientific title
The role of ascorbic acid in the expression of miRNA and mood in patients with depression: A randomized controlled trial.
Secondary ID [1] 298637 0
None
Universal Trial Number (UTN)
U1111-1236-2451
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Depression 313512 0
Condition category
Condition code
Mental Health 311944 311944 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• In this randomized controlled trial, there will be two groups of patients suffering from depression.
o Among these two groups one will be interventional group and one group will be the control group Interventional Group will be on antidepressants (conventional treatment and Ascorbic Acid 500mg orally daily once a day for three months
Intervention code [1] 327707 0
Treatment: Other
Comparator / control treatment

Control Group will be on antidepressants (conventional treatment)

Control group
Active

Outcomes
Primary outcome [1] 336995 0
Change in Hamilton depression rating scale.
Timepoint [1] 336995 0
Baseline and after three months of treatment
Secondary outcome [1] 430340 0
Change in expression levels of microRNAs, miR-132, miR-182, miR-124, miR-let7b, miR-let7C
Timepoint [1] 430340 0
At baseline and after three months of treatment
Secondary outcome [2] 430341 0
Change in blood ascorbic acid levels.
Timepoint [2] 430341 0
At baseline and after three months of treatment

Eligibility
Key inclusion criteria
Patients with a total count of 16 or more on Hamilton Depression Rating Scale (HAM-D) both men and women with an age limit between 18years to 45 years
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with sufficiently important concurrent psychiatric illness, epilepsy, bipolar affective disease, ongoing substance abuse other than cigarette smoking, suicidal attempts, pregnancy or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size: 51 per group Total 102 Subjects
Justification: The sample size is calculated with Open Epi software (REF) by taking two-sided significance level of 95%, power as 80% and ratio of unexposed to expose as one.
• Peripheral blood sample will be taken from every patient. These patients will have a next blood sample drawn after 12-weeks anti depression treatment. Laboratory investigations will be ascorbic acid levels by HPLC and miRNA levels by quantitative polymerase chain reaction
The expression levels of miRNA-132, miRNA-182, miRNA let-7b, let-7c and miRNA-124 between two groups of patients with depression was analyzed by independent sample t-test and ANOVA.
Data analysis was performed by using SPSS. A p value of <0.05 will be taken as statistically significant.
.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/02/2021
Date of last participant enrolment
Anticipated
Actual
29/07/2021
Date of last data collection
Anticipated
Actual
19/11/2021
Sample size
Target
102
Accrual to date
Final
102
Recruitment outside Australia
Country [1] 26060 0
Pakistan
State/province [1] 26060 0
Peshawar

Funding & Sponsors
Funding source category [1] 303177 0
Self funded/Unfunded
Name [1] 303177 0
Dr Shamaila Wadud
Country [1] 303177 0
Pakistan
Primary sponsor type
Individual
Name
Dr Shamaila Wadud
Address
House No 6C National bank colony warsak road Peshawar
Country
Pakistan
Secondary sponsor category [1] 317589 0
University
Name [1] 317589 0
Khyber Medical University Peshawar Pakistan
Address [1] 317589 0
Country [1] 317589 0
Pakistan
Secondary sponsor category [2] 318175 0
Hospital
Name [2] 318175 0
Mercy Teaching hospital Peshawar
Address [2] 318175 0
Country [2] 318175 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303739 0
ASRB Khyber Medical University Peshawar Pakistan
Ethics committee address [1] 303739 0
Ethics committee country [1] 303739 0
Pakistan
Date submitted for ethics approval [1] 303739 0
01/10/2019
Approval date [1] 303739 0
07/11/2019
Ethics approval number [1] 303739 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94630 0
Dr Shamaila Wadud
Address 94630 0
Peshawar Medical College Warsak Road Peshawar. Pakistan Postal Code: 25160.
Country 94630 0
Pakistan
Phone 94630 0
+923018905683
Fax 94630 0
Email 94630 0
[email protected]
Contact person for public queries
Name 94631 0
Shamaila Wadud
Address 94631 0
Peshawar Medical College Warsak Road Peshawar. Pakistan.Postal Code: 25160.
Country 94631 0
Pakistan
Phone 94631 0
+923018905683
Fax 94631 0
Email 94631 0
[email protected]
Contact person for scientific queries
Name 94632 0
Shamaila Wadud
Address 94632 0
Peshawar Medical College Warsak Road Peshawar. Pakistan.Postal Code: 25160.
Country 94632 0
Pakistan
Phone 94632 0
+923018905683
Fax 94632 0
Email 94632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Its confidential


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.