| CTRI Number |
CTRI/2021/04/032708 [Registered on: 09/04/2021] Trial Registered Prospectively |
| Last Modified On: |
08/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To know about dietary pattern and nutritional status of HIV infected children and adolescents |
|
Scientific Title of Study
|
Dietary intake and nutritional status of children and adolescents with HIV infection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Rajeshwari |
| Designation |
Director Professor |
| Affiliation |
Maulana azad medical college and associated hospitals |
| Address |
Department of pediatrics, Maulana azad medical college and associated lok nayak hospital, New delhi
Central
DELHI
110002
India |
| Phone |
01123239417 |
| Fax |
|
| Email |
rajeshwari.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Goyal |
| Designation |
Post graduate resident 2nd year |
| Affiliation |
Maulana azad medical college and associated hospitals |
| Address |
Department of pediatrics, Maulana azad medical college and associated lok nayak hospital, New delhi
Central
DELHI
110002
India |
| Phone |
09873607439 |
| Fax |
|
| Email |
goyaldivya14995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Goyal |
| Designation |
Post graduate resident 2nd year |
| Affiliation |
Maulana azad medical college and associated hospitals |
| Address |
Department of pediatrics, Maulana azad medical college and associated lok nayak hospital, New delhi
Central
DELHI
110002
India |
| Phone |
09873607439 |
| Fax |
|
| Email |
goyaldivya14995@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maulana azad medical college and associated hospitals |
| Address |
Maulana azad medical college and associated hospitals,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 K Rajeshwari |
Maulana azad medical college and associated lok nayak hospital |
ART clinic, Maulana azad medical college and associated lok nayak hospital,New delhi-110002
Central
DELHI |
01123239417
rajeshwari.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20-B20||Human immunodeficiency virus [HIV] disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children and adolescents between 6 to 18 years of age with HIV infection attending the clinic irrespective of their ART status will be enrolled |
|
| ExclusionCriteria |
| Details |
Children on special diets like gluten free diet for celiac disease, those with gastrostomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dietary patterns in children and adolescents with HIV infection |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nutritional status of children and adolescents with HIV infection |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
11/04/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Malnutrition is a major problem for children and especially for HIV-infected children since it
creates a vicious circle with HIV infection. Indeed, on one hand, malnutrition worsens HIV disease
as it has similar effects on the immune system as HIV infection. On the other hand, HIV infection increases the risk of
malnutrition, because of a high pro-inflammatory cytokine activity which can cause growth
impairment among children. HIV-related opportunistic infections such as persistent diarrhea
or oral and esophageal candidiasis have a negative impact on nutritional status among children.
Thus, malnutrition is a common complication among HIV-infected children. Among children with severe malnutrition, mortality risk is three times higher in HIV-infected children than in non-HIV-infected children. Thus, nutritional care is an essential part of the
pediatric HIV healthcare package. The adolescent period is a critical part of development in the life cycle, a time of physical and
emotional change as the body matures. The adolescent period is one of rapid growth and
development that includes physical, psychological, intellectual, and social changes. This growth
and development creates increased demands for energy and nutrients. Coupled with a chronic
infection like HIV, these adolescents are likely to suffer various nutritional deficiencies. There have been very few studies conducted in India to assess nutritional status of adolescents with
HIV, therefore there are no specific guidelines available specific to Indian adolescents with HIV
infection regarding nutritional care. So, we propose to conduct a cross-sectional observational
study to assess dietary intake and nutritional status among HIV infected children and adolescents
and its association with degree of immunodeficiency. |