| CTRI Number |
CTRI/2012/05/002677 [Registered on: 21/05/2012] Trial Registered Prospectively |
| Last Modified On: |
07/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Zinc and probiotics to enhance immunogenicity of oral vaccines |
|
Scientific Title of Study
|
Effect of probiotic and zinc supplementation on systemic immune response to oral rotavirus and oral poliovirus vaccination |
| Trial Acronym |
ZnP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CMC ZP 2012; HS-658 Version 2.0 date 28 Apr 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gagandeep Kang |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
The Wellcome Trust Research Laboratory
Department of Gastrointestinal Sciences
Christian Medical College
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
0416-228-2052 |
| Fax |
0416-228-2486 |
| Email |
gkang@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Gagandeep Kang |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
The Wellcome Trust Research Laboratory
Department of Gastrointestinal Sciences
Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
0416-228-2052 |
| Fax |
0416-228-2486 |
| Email |
gkang@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Gagandeep Kang |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
The Wellcome Trust Research Laboratory
Department of Gastrointestinal Sciences
Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
0416-228-2052 |
| Fax |
0416-228-2486 |
| Email |
gkang@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology, PATH |
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology |
| Address |
Ministry of Science and Technology, Govt. of India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PATH |
A-9, Qutab Institutional Area,
Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gagandeep Kang |
Christian Medical College |
Department of Gastrointestinal Sciences
Christian Medical College
Vellore
Vellore
TAMIL NADU |
0416-228-2052
0416-228-2486
gkang@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian Medical College Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Immunization |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactobacillus GG (contents of 1 capsule once daily in 20 ml of milk) for 6 weeks |
The factorial design will result in two arms receiving each of the two interventions (zinc or probiotics) and two arms receiving placebo for each interventions. |
| Comparator Agent |
Placebo for probiotic (contents of 1 capsule in 10 ml of milk) once daily for 6 weeks |
Placebo for probiotic is inulin |
| Comparator Agent |
Placebo for zinc syrup 10 ml once daily for 6 weeks
|
Zinc placebo is lactose
|
| Intervention |
Zinc sulphate heptahydrate syrup (10mg/ml) 10 ml once daily for 6 weeks |
The factorial design will result in 2 arms of the study receiving zinc and two arms receiving probiotic |
|
|
Inclusion Criteria
|
| Age From |
35.00 Day(s) |
| Age To |
41.00 Day(s) |
| Gender |
Both |
| Details |
• Infants 35-41 days old.
• Live in area under surveillance.
• Current weight ≥3.2 kg.
• No syndromic evidence of immunocompromise.
• No prior illness requiring hospitalization.
• No current medical condition as determined by medical doctor which precludes study involvement.
• Available for follow up for duration of study (through approximately 14 weeks of age).
• Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent.
|
|
| ExclusionCriteria |
| Details |
• Child has history of atopic symptoms.
• Child has a known digestive system defect.
• Child has history of chronic diarrhea.
• Child has major congenital anomalies.
• Child has received a prior dose of rotavirus vaccine.
• Child has received a prior dose of polio vaccine (beyond the birth dose).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To evaluate the serologic immune response to rotavirus vaccine among Indian infants receiving zinc supplementation or a probiotic given daily for a week prior to the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc or probiotic placebo
|
4 weeks after the second dose of immunization
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To evaluate the serologic immune response to oral polio vaccine among Indian infants receiving zinc or probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral polio vaccine compared to those receiving a zinc or probiotic placebo |
4 weeks after the second dose of immunization |
|
|
Target Sample Size
|
Total Sample Size="560"
Sample Size from India="560"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/07/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 single center,
double blind, double-dummy, placebo controlled, randomized parallel clinical
trial with four groups will enroll approximately 560 total study participants
at approximately 5 weeks of age residing in proximity to the Christian Medical
College in Vellore. As part of the
parallel design, study participants will be randomized to one of the four
groups following a 1:1:1:1 allocation to receive zinc supplement and probiotic supplement
(N=140), zinc supplement and probiotic placebo (N=140), zinc placebo and
probiotic supplement (N=140), or zinc placebo and probiotic placebo
(N=140). Serum specimens collected at 6 and 14 weeks will be analyzed for anti-rotavirus IgA and for neutralizing antibodies to poliovirus type 3 in order to determine whether or not supplementation with probiotics and/or zinc can enhance the proportion of children who respond to oral vaccination by at least 15%.
|