Effect of Zinc Supplementation on Response to Oral Polio Vaccine in Infants in Pakistan

NCT01229579 | Completed

• 1 other identifier: 1291-Peds/ERC-09
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Pakistan is one of the 4 developing countries where cases of poliomyelitis are still being identified. Despite the incessant efforts by WHO and UNICEF, this disease is far from control. There is a need to develop new and innovative strategies to contain the disease and eradicate it from the countries where new cases continue to be identified. Zinc is an essential component of scores of enzymes in the human body. Recent reports have indicated that this trace element along with other micronutrients enhances the protective functions of immune cells. Moreover, zinc deficiency leads to dysregulation of balanced host responses to infection resulting into decreased antibody production and suppressed immunity. Zinc is also an essential cofactor for thymulin which is known to modulate cytokine release and induce immune cell proliferation. Zinc deficiency is also found to impair an individual's epithelial barrier function, which may further depress the vaccine entry into the mucosal cells. Role of zinc in the prevention of diarrheal diseases and other infections in children is well documented. However, there are very few reports about its contribution to enhanced immunity by supporting body's natural defense system. Zinc insufficiency is widespread in socioeconomically deprived children in South Asia and the recent most national nutrition survey (2003) . Moreover, diarrhea is also very common in infants in Pakistan. Such diarrheal episodes can limit entry of attenuated polio virus into the mucosal cells, thereby, leading to inadequate immune response. Association between recent diarrheal history and increased vaccine failure in infants has been shown in a study from Brazil. The recent Lancet Nutrition series has also recommended regular zinc supplementation to address child undernutrition and stunting and underscored the need to treat diarrheal episodes with zinc to expedite recovery. Other recent studies of zinc supplementation in low birth weight infants in South Asia have also shown significant improvement in diarrheal disease burden and mortality. On the basis of these lines of evidence, it is possible that some of the cases of vaccine failure in this region could be a consequence of compromised immunity and, hence, diminished response to OPV. This could potentially be reversed by addressing such gross undernutrition and micronutrient deficiencies. It can thus be hypothesized that zinc supplementation at community scale would enhance the immune response in infants to OPV. In order to test this research question, the investigators propose to undertake 12-month randomized controlled trial among a cohort of Pakistani infants of 0-14 days of age. Such a trial would enable us to understand the synergistic role of zinc (if any) with OPV in enhancing immune response against polio and sero-conversion rates.

Conditions

Poliomyelitis

Keywords

poliomyelitis; OPV; zinc supplement; diarrhea; placebo; double blind randomized control trial; elemental zinc; seroconversion; bOPV; infants; immunity

Outcome Measures

Primary Outcomes (1)

• Seroconversion rates of polio virus (type 1 and type 3), from blood samples collected at the time of recruitment, at 6 weeks and 18 weeks.

  From birth to 18 weeks

Secondary Outcomes (2)

• Prevalence of excretion of poliovirus serotypes 1, 3 at 0 and 7 days after the administration of bOPV

  18 and 19 Weeks

• Effect of zinc supplementation on growth of infants

  Day 14 to 18 weeks

Study Arms (2)

Zinc Supplement

EXPERIMENTAL

2.5 ml Zinc supplement syrup daily containing 10 mg of elemental zinc

Drug: Zinc Sulfate

Placebo

PLACEBO COMPARATOR

2.5 ml supplement syrup daily without elemental zinc

Other: Placebo

Interventions

Zinc Sulfate DRUG

2.5 ml Zinc supplement syrup daily containing 10 mg of elemental zinc from day 14 to 18 weeks of age.

Zinc Supplement

Placebo OTHER

2.5 ml placebo syrup daily with containing no elemental zinc from day 14 to 18 weeks of age.

Placebo

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 14 days of healthy newborns

You may not qualify if:

• Infants beyond 14 days of age
• Preterm infants (\< 37 weeks gestation or \< 2 kg birth weight).

Sponsors & Collaborators

• Aga Khan University: lead
• World Health Organization: collaborator

Study Sites (1)

Project Office, Aga Khan University, Matiari

Matiari, Sindh, 71000, Pakistan

Location

MeSH Terms

Conditions

Poliomyelitis; Diarrhea; HIV Seropositivity

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founding Director, Centre of Excellence in Women and Child Health

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 28, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

PA (1)