CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2018/04/013290 [Registered on: 16/04/2018] Trial Registered Retrospectively

Last Modified On:

08/04/2018

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

Study of outcomes after vitamin D supplementation in HIV positive children

Scientific Title of Study

Study of Effect of Vitamin D supplementation in Human Immunodeficiency Virus infected children

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	PRABHA VERMA
Designation	JUNIOR RESIDENT
Affiliation	MOTI LAL NEHRU MEDICAL COLLEGE, ALLAHABAD
Address	DEPARTMENT OF PEDIATRICS, SAROJINI NAIDU CHILDREN HOSPITAL, HASHIMPUR CHAURAHA,ALLAHABAD Allahabad UTTAR PRADESH 211002 India
Phone	8299472700
Fax
Email	prabha.verma26@gmail.com

Details of Contact Person
Scientific Query

Name	ANUBHA SHRIVASTAVA
Designation	ASSOCIATE PROFESSOR
Affiliation	MOTI LAL NEHRU MEDICAL COLLEGE, ALLAHABAD
Address	HEAD OF THE DEPARTMENT OFFICE, SAROJINI NAIDU CHILDREN HOSPITAL, HASHIMPUR CHAURAHA, ALLAHABAD Allahabad UTTAR PRADESH 211002 India
Phone	9236804326
Fax
Email	anubhashrivastava@rediffmail.com

Details of Contact Person
Public Query

Name	ANUBHA SHRIVASTAVA
Designation	ASSOCIATE PROFESSOR
Affiliation	MOTI LAL NEHRU MEDICAL COLLEGE, ALLAHABAD
Address	HEAD OF DEPARTMENT OFFICE, DEPARTMENT OF PEDIATRICS, SAROJINI NAIDU CHILDREN HOSPITAL, HASHIMPUR CHAURAHA, ALLAHABAD Allahabad UTTAR PRADESH 211002 India
Phone	9236804326
Fax
Email	anubhashrivastava@rediffmail.com

Source of Monetary or Material Support

Moti Lal Nehru Medical College

Primary Sponsor

Name	MOTI LAL NEHRU MEDICAL COLLEGE
Address	MOTI LAL NEHRU MEDICAL COLLEGE, ALLAHABAD
Type of Sponsor	Government 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
PRABHA VERMA	Swaroop Rani nehru hospital	2/40, ANTIRETROVIRAL THERAPY CENTRE, DEPARTMENT OF MEDICINE, near ICU Medicine Allahabad UTTAR PRADESH	8299472700 prabha.verma26@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethic Committe	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	VITAMIN D deficiency,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NO TREATMENT	HIV patients having sufficient itamin D levels
Intervention	VITAMIN D supplementatiom	Vitamin D supplemented in HIV patients with deficeint or insufficient Vitamin D levels. 2,40,000 IU stat on day 1 in form of 4 vitamin D3 sachets containing 60,000IU followed by vitamin D3 drops daily for 12 weeks 0.5 ml (400 IU)

Inclusion Criteria

Age From	18.00 Month(s)
Age To	18.00 Year(s)
Gender	Both
Details	All HIV infected children with parents with 1) Age 18 months-18 years 2) On Highly Active Anti Retroviral Therapy

ExclusionCriteria

Details

HIV infected children patients
1) Receiving any form of Vitamin D or Calcium supplementation
2) Having pre-existing tuberculosis or any other opportunistic infection

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
IMMUNITY STATUS wuth CD4 count	4 months

Secondary Outcome

Outcome	TimePoints
OPPORTUNISTIC INFECTIONS	4 months

Target Sample Size

Total Sample Size="51"
Sample Size from India="51"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51"

Phase of Trial

N/A

Date of First Enrollment (India)

15/12/2016

Date of Study Completion (India)

05/09/2017

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="1"
Days="1"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

NONE YET

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

This is a Non - Randomized active controlled trial to study the effect of supplementation of Vitamin D in HIV ( human immunodeficiency virus) infected children on Highly Active Anti-Retroviral Treatment. Vitamin D levels were done in 51 HIV patients at enrolment .Patients ere divided in 4 groups by US endocrine Society Classification for Vitamin D levels...GROUP1- HIV patients with vitamin D deficiency, GROUP 2- HIV patients with insufficient Vitamin D levels, GROUP 3 - HIV infected patients with vitamin D sufficient levels , GROUP 4- HIV infected patients with vitamin D toxicity. GROUP 1 & 2 Patients were supplemented with Vitamin D 2,40,000 IU oral cholecalciferol sachets on day 1 followed by vitamin D3 drops 0.5ml (400 IU) daily for 12 weeks (1ml = 800 IU) and vitamin D levels were repeated after 4 months. GROUP 3 & 4 placebo ( tab folic acid was given for 12 weeks. Primary Outcomes will be CD4 counts of both groups 1 and 2 will be compared .Secondary outcomes will be 1) Incidence of opportunistic infections in both group 1 and 2.... 2) comparison of CD4 count after vitamin D supplementation in Vitamin D deficient HIV infected children. At final evaluation,the above trial concluded that , CD4 count increased in Group 1,2 and 3 , there was no significant difference in mean CD4 count at all periods among the 3 groups. Similarly, opportunistic infections decrease in group 1,2 and 3 but the mean number of opportunistic infections between the groups at all periods did not differ significantly.