Evaluation of effect of DHA drop in development progression of gross motor and head circumference in children between 6 month and one years old Has a head growth disorder referred to Hazrat Masoumeh Hospital in Qom in 2022-2023
Investigating the effect of DHA on the development of children between 6 months and one year
Design
Clinical trial, randomization with R software. Randomized to one of two intervention or placebo groups. in a double-blind manner
The number of samples is 60 people. Based on a study in Urmia.
Settings and conduct
Two groups of children. Between 6 months and 1 year in Masoumeh hospital in Qom with developmental disorder and small head circumference. For 6 months, one group was given only vitamin AD drops and the second group was given AD and DHA drops in the amount of 40 mg. The therapist and the patient do not know the drops.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children, both boys and girls, between the ages of 6 months and one year, with small head circumference according to age and developmental disorder
Exit criteria:
Allergy symptoms in children
Intolerance of drops
Lack of interest of parents to continue studying
Premature babies, cerebral palsy, metabolic, twins or multiples, history of head trauma, history of brain infection
Intervention groups
The main group received AD and DHA drops in the amount of 40 mg and the control group only received AD vitamin drops. double blind The results before and after the start of the intervention are extracted and compared from the checklist of the questionnaire. The results of the blood test and the head circumference are checked before and after the intervention. Bar.
Main outcome variables
the degree of evolution in gross movements; growth around the head; blood HDL level; blood LDL level; Blood TG level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220920056000N1
Registration date:2023-11-11, 1402/08/20
Registration timing:prospective
Last update:2023-11-11, 1402/08/20
Update count:0
Registration date
2023-11-11, 1402/08/20
Registrant information
Name
elham farasat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3162 5224
Email address
farasat_med@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-26, 1402/10/05
Expected recruitment end date
2024-03-24, 1403/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of DHA drop in development progression of gross motor and head circumference in children between 6 month and one years old Has a head growth disorder referred to Hazrat Masoumeh Hospital in Qom in 2022-2023
Public title
Evaluation of effect of DHA drop in development progression of gross motor and head circumference in children between 6 month and one years old Has a head growth disorder referred to Hazrat Masoumeh Hospital in Qom in 2022-2023
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children, both boys and girls, between the ages of 6 months and 1 year, who are referred to Hazrat Masoumeh Hospital in Qom with small head circumference according to their age and developmental disorder.
Exclusion criteria:
Allergy symptoms in children
Intolerance of drops and vomiting
Lack of interest of parents to continue studying
Premature babies
Cerebral Palsy
Metabolic disorder
Two or more twins
History of head trauma
History of brain infection
Age
From 6 months old to 1 year old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization pattern: block - randomization unit: individual - randomization tool: R software - in a two-way blind way
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining a written consent, medicine is given for 6 months, one group is given only vitamin AD drops and the second group is given AD and DHA drops in the amount of 40 mg. The appearance of the drops is the same and neither the therapist nor the patient can distinguish the type of drops
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Pediatric Clinical Research Development Unit, Hazrat Masoumeh Educational and Therapeutic Center, Imam Khomeini Street after Shahid Zainuddin Square, Qom, Iran.
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2022-08-29, 1401/06/07
Ethics committee reference number
IR.MUQ.REC.1401.119
Health conditions studied
1
Description of health condition studied
developmental disorder
ICD-10 code
G93.9
ICD-10 code description
Disorder of brain, unspecified
Primary outcomes
1
Description
Size around the head of children 6 months to one year
Timepoint
Once every 2 months until 6 months, i.e. 4 times (beginning of birth, 2 months, 4 months, and 6 months)
Method of measurement
Measure and compare with graph
2
Description
Development of gross movements of children from 6 months to one year
Timepoint
Once every 2 months until 6 months, i.e. 4 times (beginning of birth, 2 months, 4 months, and 6 months)
Method of measurement
Evolution Questionnaire
Secondary outcomes
1
Description
Ability to acquire movement skills
Timepoint
Once every 2 months until 6 months, i.e. 4 times (beginning of birth, 2 months, 4 months, and 6 months)
Method of measurement
Evolution Questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: children, both boys and girls (whose number will be equal in both groups) between the ages of 6 months and 1 year, who are referred to Hazrat Masoumeh Hospital in Qom due to developmental disorders and small head circumference. DHA is given to patients in the amount of 40 mg
Category
Treatment - Drugs
2
Description
Control group: children, both boys and girls (whose number will be the same in both groups) between the ages of 6 months and 1 year, who are referred to Hazrat Masoumeh Hospital in Qom due to developmental disorders and small head circumference after obtaining A written consent is given for 6 months of medication and they only receive vitamin AD drops
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Masoumeh Hospital in Qom
Full name of responsible person
Dr. Mohsen Mullamohammadi
Street address
Qom. Imam Khomeini Street - after Shahid Zainuddin Square - Hazrat Masoumeh Hospital
City
Qom
Province
Ghoum
Postal code
3719815539
Phone
+98 25 3162 5224
Email
farasat_med@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohsen Mullamohammadi
Street address
Qom. Imam Street - after Zainuddin Square - Hazrat Masoumeh Hospital
City
Qom
Province
Ghoum
Postal code
3719815539
Phone
+98 25 3162 5224
Email
farasat_med@yahoo.com
Grant name
Vice President of Research, Qom University of Medical Sciences
Grant code / Reference number
2661
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohsen Mullamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Qom- Imam Street after Zainuddin Square- Hazrat Masoumeh Hospital
City
Qom
Province
Ghoum
Postal code
3719815539
Phone
+98 25 3162 5224
Email
farasat_med@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Elham Farasat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Emam blv
City
Qom
Province
Ghoum
Postal code
3719815539
Phone
+98 25 3162 5224
Fax
Email
farasat_med@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Elham Farasat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Emam blv
City
Qom
Province
Ghoum
Postal code
3719815539
Phone
+98 25 3162 5224
Fax
Email
farasat_med@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A part of the data such as the information related to the main outcome or the like can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For use in similar research projects
From where data/document is obtainable
Elham farasat - Hazrat Masoumeh Hospital, Qom
What processes are involved for a request to access data/document