| CTRI Number |
CTRI/2024/07/069847 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To look for nutritional deficiencies in children treated for rickets |
|
Scientific Title of Study
|
Assessment of nutritional deficiencies post treatment in children with nutritional rickets |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veanupreethaa V S |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of paediatrics,Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
9487993054 |
| Fax |
|
| Email |
venupreetha285@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aashima Dabas |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of paediatrics,Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
9968604424 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aashima Dabas |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of paediatrics,Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
9968604424 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2,Bahadur Shah Zafar Marg,New Delhi - 110002 |
| Type of Sponsor |
Government 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 Veanupreethaa V S |
Maulana Azad Medical College and associated Lok Nayak |
Ward 15,Department of Peadiatrics,Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI |
9487993054
venupreetha285@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E550||Rickets, active, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children of age 6 months to 5 years who were treated for nutritional rickets in the preceding 12-24 months |
|
| ExclusionCriteria |
| Details |
Children with malabsorption syndrome.
Children with any other chronic systemic illness.
Children who received more than or equal to 60,000 IU of Vitamin D in the last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of children treated for nutritional rickets with low vitamin D levels(Less than 20 ng per ml) |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean daily macronutrient (Carbohydrate, Protein, Fat) and micronutrient (Vitamin D, Vitamin C, Calcium and Iron) intake. |
1 year |
| Anthropometric assessment – Weight for age Z score, Height/Length for age Z score, Weight for Height Z score, head circumference and Mid Upper Arm Circumference (MUAC) Z score. |
1 year |
| Proportion of patients with scurvy, anaemia, vitamin B deficiency |
1 year |
| Mean Calcium, Phosphorus, ALP, PTH, Iron, Vitamin C, Folate, Ferritin, S. Albumin levels |
1 year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
05/10/2024 |
| 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="0"
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
|
As the cause of rickets is predominantly nutritional deficiency, a detailed nutritional assessment of other micronutrients and macronutrients will be an essential component of wholesome management. Recent UNICEF5 data also shows that micronutrient deficiencies affect more than 340 million children under 5 globally, with India having 38.4 per cent children with stunting.The current study was planned to assess the nutritional intake and micronutrient deficiencies in children who have been treated for nutritional rickets.The study will enrol 90 previously treated children with rickets to analyse their current macronutrient and micronutrient intake. Blood sample will be taken to estimate the levels of calcium, phosphorus, ALP, vitamin D, parathyroid hormone, iron, folate and vitamin C. Any child who is found with calcium and/or vitamin D deficiency will be treated as per standard guidelines. |