Daily Zinc Supplement Effect on Prevention of Diarrhea and Acute Respiratory Infections in Children Less Than Five Years
Condition: Zinc Deficiency; Child Nutrition Disorders
MeSH terms: Infections; Respiratory Tract Infections; Nutrition Disorders; Child Nutrition Disorders; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Zinc deficiency in children is a major problem which leads to compromised immunity and
      accordingly repeated infections. This study aims to investigate the effect of supplementing
      zinc to decrease the incidence of diarrhea and respiratory illness in children between 6
      months and 5 years in Paediatric Outpatient Clinic in Ain Shams University Hospital.
    

Detailed description: 
      Zinc is a trace element that plays essential roles in protein and lipid metabolism, cell
      growth and differentiation, and the immune system; either cellular or humoral immunity. There
      is no specialized zinc storage system in the body, accordingly, a daily intake of zinc is
      required to maintain a steady state. Zinc deficiency can cause compromised immune function,
      accordingly this can lead to infections and growth defects among young children According to
      literature review search, there is lack of studies on the preventive effect of zinc
      supplementation on Egyptian children less than five years old; the age group which is known
      by the suboptimal nutritional status and the high prevalence of infection. Accordingly, the
      present study is aiming to evaluate the impact of 4 months of daily zinc supplementation on
      the incidence of diarrhea and respiratory illness and to detect the frequency of daily
      dietary intake of zinc-rich food children between 6 months and 5 years in Paediatric
      Outpatient Clinic in Ain Shams University Hospital.

      Objectives:

        1. To evaluate the impact of 4 months of daily zinc supplementation on:

           - the incidence and the severity of diarrheal morbidity.

           - the incidence of acute respiratory infection.

        2. To measure the level of serum zinc in children between 6 months and 5 years attending
           Paediatric Outpatient Clinic in Ain Shams University Hospital.

        3. To compare between children who had initially low serum zinc level with those with
           normal level as regard the reduction in the incidence of diarrhea and respiratory
           illness.

        4. To measure the frequency of daily dietary intake of zinc-rich food in children between 6
           months and 5 years attending Paediatric Outpatient Clinic in Ain Shams University
           Hospital.

           Methodology:

           • Study type: a single blinded, randomized controlled trial.

           • Study setting: Paediatric Outpatient Clinic in Ain Shams University Hospital.

             -  Sampling method:

           A convenience sample of children between 6 months and 5 years was recruited from the
           Paediatric Outpatient Clinic in Ain Shams University Hospital.

           • Study population: Eligible children aged between 6 months and 5 years attending
           Paediatric Outpatient Clinic in Ain Shams University Hospital was included.

           Randomization and allocation:

           Random assignment of the sampled children to either the study group receiving zinc or
           the control group receiving placebo was done. The study was single-blinded, where the
           children's mothers won't know either their children are enrolled in the study group or
           the control group.

           • Study tool:

           - Baseline questionnaire: Structured interview questionnaire was used at the first
           meeting with the mother to collect baseline data. The questionnaire includes baseline
           characteristics, such as child age, child sex, family size, child rank, child feeding
           practices (breastfeeding), maternal literacy, vaccination history and birth weight.

           Also, the baseline questionnaire assessed the occurrence and duration of diarrhea and
           respiratory illness in the past month before the start of zinc supplementation.
           Questions are adopted from the Demographic and Health Survey (DHS) questionnaire
           (Ministry of Health and Population/Egypt, 2015).

           - Questionnaire for Zinc-Rich Food Intake Pattern:

           The questionnaire, a dietary history recall instrument, was used to elicit and capture
           information on frequency of daily dietary intake over previous 1 month of two categories
           of zinc-rich foods namely:

             -  Foods of animal origin devoid of zinc antinutritional factor (liver, fish, milk,
                eggs)

             -  Food of vegetable origin including those known to contain a zinc antinutritional
                factor (cereals, beans)

                - Serum zinc: A blood sample was collected from all included children at the
                beginning of the study to estimate the baseline serum zinc level. Venous blood
                samples (about 4 milliliters) were collected in heparinised tubes and transported
                to the laboratory for centrifugation and serum zinc estimation using atomic
                absorption spectrophotometer graphites.

                - Intervention: The children were randomized to receive daily zinc sulphate or
                placebo. The elemental zinc dose was 3 mg/ day to children whose weight is less
                than 10 kg and 7 mg/ day to children whose weight is 10 kg or more. This dose is
                more than the recommended dietary allowance for supplementation so as to allow for
                possible impairment in absorption of ingested zinc among children as a result of
                consumption of a predominantly phytate-rich cereal-based diet, bacterial
                overgrowth, and protozoal or parasitic infestations. At the same time the dose
                won't exceed the upper tolerable level for zinc (World Health Organization and Food
                and Agriculture Organization of the United Nations, 2005).

           One bottle that contained 150 mL was kept in the child's home and replaced monthly. The
           placebo was non-nutritious and vitamin-free, designed to be identical to the zinc syrup
           in colour, odour, and taste.

           - Follow up: Each month, during the child visit to the Paediatric Outpatient Clinic, or
           through a telephone call, the mother was asked certain questions regarding the
           occurrence and duration of diarrhea and respiratory illness in the past month. Questions
           are adopted from the Demographic and Health Survey (DHS) questionnaire (Ministry of
           Health and Population/Egypt, 2015).

           - Pre- and posttreatment anthropometric parameters (weight and length\ height
           measurements) were recorded.

           Nutritional status was assessed by measuring weight and height using standard methods
           and calculating weight for-age and weight-for-height Z scores. Weight was measured to
           nearest 100 gm using an electronic scale.
    

Intervention name(s): zinc; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): The zinc syrup was prepared with a concentration of 7 mg zinc in each 5 ml solution. Accordingly, children with weight more than 10 kg were asked to take 5 ml syrup daily, while children with weight less than 10 kg were asked to take 2.5 ml daily.; Children with weight more than 10 kg were asked to take 5 ml syrup daily, while children with weight less than 10 kg were asked to take 2.5 ml daily.
Other intervention name(s): zinc sulphate; inactive substance
Intervention MeSH terms: Zinc; Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: zinc; diarrhea; Respiratory Tract Infections; prevention