| 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
|
|
|
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
|
|
|
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.
|