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Trial registered on ANZCTR


Registration number
ACTRN12625000084482
Ethics application status
Approved
Date submitted
23/11/2024
Date registered
24/01/2025
Date last updated
24/01/2025
Date data sharing statement initially provided
24/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Folic acid supplementation on appetite/nutritional status in pre-school children.
Scientific title
Effect of folic acid supplementation on appetite in pre-school children -Randomized control trial
Secondary ID [1] 313452 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nutritional status 335853 0
appetite 336399 0
Condition category
Condition code
Diet and Nutrition 332427 332427 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All children presenting to the paediatric OPD, between the ages 3 and 5 years who were below the 50th percentile on the growth chart were enrolled in the study.
Children having any chronic condition such as celiac disease, diabetes mellitus, neoplasia or anemia were excluded from the study.
Children were divided in to two groups A and B(control group), each consisting of 22 children. Group A patients were to receive folic acid in a dose of 200µg/day, given as crushed half tablet of Myfol-R while Group B(control group) was given a placebo in the form of a glucose capsule for 3 months . Compliance to the drug was ensured by counselling the parents and empty strips or packets of tablets were seen at each monthly follow up. Data was collected using a specialized questionnaire designed for the trial which also included the Child Eating Behavior Questionnaire (CEBQ)(11). This questionnaire was filled at baseline and at 3 months follow up of the patients. Primary outcome of the trial was to observe any improvement in the appetite at 3 months using the CEBQ. Secondary outcomes included improvement in the nutritional status as seen by change in the BMI, percentile on growth chart and change in hemoglobin. Side effects of folic acid therapy were also noted.
Intervention code [1] 330027 0
Treatment: Other
Comparator / control treatment
Children will be divided in to two groups A(treatment group) and B(control group) by lottery method, each consisting of 25 children. Control group was given a placebo in the form of a glucose capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 339978 0
Change in dietary intake
Timepoint [1] 339978 0
Data will be collected using a specialized questionnaire designed for the trial which will include Child Eating Behavior Questionnaire (CEBQ).This questionnaire will be filled at baseline and at 3 months follow up of the patients after initiation of folic acid.
Primary outcome [2] 340455 0
Change in BMI
Timepoint [2] 340455 0
base line and on 3 months follow up
Primary outcome [3] 340456 0
Change in haemoglobin level
Timepoint [3] 340456 0
baseline haemoglobin and on 3months follow up
Secondary outcome [1] 444083 0
N/A
Timepoint [1] 444083 0
N/A

Eligibility
Key inclusion criteria
All children presenting to the paediatric OPD, between the ages 3 and 5 years who were below the 50th percentile on the growth chart were enrolled in the study.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children having malnutrition or any chronic condition such as celiac disease, diabetes mellitus, neoplasia or anemia, or non-consented patients will be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like lottery method .
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/01/2025
Date of last participant enrolment
Anticipated
13/04/2025
Actual
Date of last data collection
Anticipated
15/04/2025
Actual
Sample size
Target
60
Accrual to date
50
Final
Recruitment outside Australia
Country [1] 26755 0
Pakistan
State/province [1] 26755 0
islamabad

Funding & Sponsors
Funding source category [1] 317891 0
Hospital
Name [1] 317891 0
KRL Hospital G-9/1 service road islamabad
Country [1] 317891 0
Pakistan
Primary sponsor type
Hospital
Name
KRL Hopital G9/1 service road Islamabad Pakistan
Address
Country
Pakistan
Secondary sponsor category [1] 320231 0
None
Name [1] 320231 0
Address [1] 320231 0
Country [1] 320231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316576 0
Ethical review board of KRL HOSPITAL ISLAMABAD PAKISTAN
Ethics committee address [1] 316576 0
Ethics committee country [1] 316576 0
Pakistan
Date submitted for ethics approval [1] 316576 0
30/10/2024
Approval date [1] 316576 0
12/11/2024
Ethics approval number [1] 316576 0
KRL-HI-PUB-ERC/NOV24/31

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

Contacts
Principal investigator
Name 138302 0
Dr AMBER LATIF
Address 138302 0
KRL Hospital, Muhammad Tufail Niazi Rd, G-9 Mauve Area G 9/1 G-9, Islamabad, Islamabad Capital Territory 44000
Country 138302 0
Pakistan
Phone 138302 0
+923438955971
Fax 138302 0
Email 138302 0
[email protected]
Contact person for public queries
Name 138303 0
Amber Latif
Address 138303 0
KRL Hospital, Muhammad Tufail Niazi Rd, G-9 Mauve Area G 9/1 G-9, Islamabad, Islamabad Capital Territory 44000
Country 138303 0
Pakistan
Phone 138303 0
+923438955971
Fax 138303 0
Email 138303 0
[email protected]
Contact person for scientific queries
Name 138304 0
Amber Latif
Address 138304 0
KRL Hospital, Muhammad Tufail Niazi Rd, G-9 Mauve Area G 9/1 G-9, Islamabad, Islamabad Capital Territory 44000
Country 138304 0
Pakistan
Phone 138304 0
+923438955971
Fax 138304 0
Email 138304 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• case-by-case basis at the
discretion of Primary Sponsor, etc.

Conditions for requesting access:
• -

What individual participant data might be shared?
• INCLUDING AGE , GENDER AND OUTCOME

What types of analyses could be done with individual participant data?
• ANY RESEARCH PURPOSE

When can requests for individual participant data be made (start and end dates)?
From:
start date 13-11-2024
end date 15-03-2025

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24365Ethical approval    DOC-20241121-WA0019..pdf



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.