Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
NCT ID: NCT01616693
Last Updated: 2018-12-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
620 participants
INTERVENTIONAL
2012-07-31
2013-07-31
Brief Summary
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This study enrolled infants 5 weeks old living in urban Vellore, India to assess the effects of daily zinc (5 mg), probiotic (1010 Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix,GlaxoSmithKline Biologicals) given at 6 and 10 weeks of age. Probiotics and zinc (or placebo) were provided for six weeks. A single dose of test product was administered daily one week prior to first study dose of rotavirus and polio vaccines through 1 week following second study dose of rotavirus and polio vaccines.
Detailed Description
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1. To evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus immunoglobulin A (IgA) antibodies) among Indian infants receiving zinc supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc placebo.
2. To evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus IgA antibodies) among Indian infants receiving probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a probiotic placebo.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Zinc and probiotic
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
Probiotic
A capsule that contains at least 1 x 10\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.
Zinc
Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Zinc alone
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc
Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo
The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no Lactobacillus rhamnosus GG. The contents of the capsule were given once daily orally.
Rotavirus vaccine
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Probiotic alone
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic
A capsule that contains at least 1 x 10\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.
Zinc placebo
The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.
Rotavirus vaccine
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Placebo
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo
The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no Lactobacillus rhamnosus GG. The contents of the capsule were given once daily orally.
Zinc placebo
The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.
Rotavirus vaccine
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Interventions
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Probiotic
A capsule that contains at least 1 x 10\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.
Zinc
Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo
The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no Lactobacillus rhamnosus GG. The contents of the capsule were given once daily orally.
Zinc placebo
The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.
Rotavirus vaccine
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Live in area under surveillance
* Current weight ≥3.2 kg
* No syndromic evidence of immunocompromise as determined by medical doctor
* 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
Exclusion Criteria
* 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)
5 Weeks
16 Weeks
ALL
Yes
Sponsors
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Christian Medical College, Vellore, India
OTHER
Ministry of Science and Technology, India
OTHER_GOV
PATH
OTHER
Responsible Party
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Principal Investigators
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Gagandeep Kang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Christian Medical Center, Vellore, India
Locations
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Christian Medical Center, Vellore
Vellore, Tamil Nadu, India
Countries
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Other Identifiers
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CMC ZP 2012; PATH HS-658
Identifier Type: -
Identifier Source: org_study_id