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CTRI Number  CTRI/2025/03/081672 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Anemia and vitamin D deficiency in children with Down Syndrome 
Scientific Title of Study   Assessment of clinical profile, anemia and vitamin D status in children with Down syndrome. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaidehi Rakholia 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Paediatrics, Kastruba Medical College, Manipal, Udupi
Department of Paediatrics, Kastruba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India 
Phone  9818801468  
Fax    
Email  vaidehi.rakholia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Koushik H 
Designation  Associate Professor  
Affiliation  KMC, Manipal 
Address  Department of Paediatrics, Kastruba Medical College, Manipal
Department of Paediatrics, Kastruba Medical College, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9242308804  
Fax    
Email  koushik.h@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Leslie Lewis 
Designation  Professor and HOD 
Affiliation  KMC, Manipal 
Address  Department of Paediatrics, Kastruba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202923167  
Fax    
Email  leslie.lewis@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Department of Pediatrics, Kasturba Medical college 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaidehi Rakholia  Kasturba Hospital  Department of Pediatrics, Women and Child block, Kasturba Medical College, Manipal Udupi
Udupi
KARNATAKA 
08202923167

vaidehi.rakholia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and Kasturba Hospital Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q909||Down syndrome, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All children between 1 month to 18 years with a diagnosis of Down syndrome will be included 
 
ExclusionCriteria 
Details  Parents unwilling to consent for inclusion in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
At enrollment in the study,
1. frequency of anemia in children with down syndrome at KH Manipal
2. Frequency of Vitamin D deficiency in children with Down syndrome at KH Manipal
3. Average age of mother at conception pf children with Down syndrome at KH Manipal 
At enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
1.Frequency of characteristic physical examination findings in children with Down syndrome at Kasturba hospital, Manipal
2.Maternal risk factors in children with Down syndrome at KH Manipal

 
At enrollment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   There is paucity of information regarding anaemia and vitamin D status of children with Down syndrome in India. Maternal age is a known risk factor for Down syndrome. Studies show that there are modifiable risk factors associated with Down syndrome too, like exposure to tobacco and oral contraceptives. With this study we will study the modifiable risk factors in mothers of children with Down syndrome.

Children between the age of 1 month and 18 years with cytologically confirmed Down syndrome will be included in the study after parental consent is obtained. The children will be included on their first visit to the hospital after the beginning of the study. The history of children with Down syndrome at diagnosis including antenatal history, anomaly scans, age of parents at conception, family history, triple marker screening during pregnancy and presenting complaints will be noted along with relevant past history and medical history. Anthropometric examination will be done with the help of electronic weighing scale, non stretchable measuring tape and height measuring scale to record the weight, height, and head circumference. The values will be assessed with respect to Down syndrome charts (Cronk chart). Detailed physical examination will be done and recorded in a preformed proforma. The results of investigations done for screening for anaemia and Vit D status as done according to standard practice guidelines will be recorded. History suggestive of atlantoaxial instability assessment and assessment for renal and cardiac screening, and thyroid screening will be noted. 


Outcome : Maternal age, exposure to tobacco and contraception before conception, consanguinity, anomaly scan results, percentage of children with anemia, vitamin D deficiency and aetiology if identified for the same. Percentage of children with Down syndrome with atlantoaxial instability, cardiac anomalies, renal anomalies.

 
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