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Effect of Zinc and Vitamin A Supplementation on Diarrhea, Physical Growth and Immune Response in Malnourished Children

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ClinicalTrials.gov Identifier: NCT00272116
Recruitment Status : Completed
First Posted : January 4, 2006
Last Update Posted : April 3, 2012
Sponsor:
Collaborators:
European Commission
World Health Organization
Norwegian Council of Universities’ Committee for Development Research and Education
Information provided by (Responsible Party):
NBhandari, Society for Applied Studies

Brief Summary:

Zinc deficiency is common in developing country children, as food intakes are often low, foods from animal sources are infrequently used, the bioavailability of zinc from staple cereal-based diets is limited and zinc losses occur during recurring diarrheal illnesses. Zinc deficiency is associated with impairment in immunological and other defenses against infection and increased rates of serious infections. Due to limitations in currently used biochemical markers, supplementation trials in populations likely to be deficient provide a reliable means of assessing health consequences of zinc deficiency.

A significantly lower incidence and prevalence of diarrhea has been observed in zinc supplemented developing country children in several placebo-controlled trials. The effect of routine zinc supplementation on lower respiratory tract infection is still unclear. We, therefore, evaluated the impact of daily zinc supplementation in a representative sample of children aged 6 to 30 months enrolled from a New Delhi slum area, with a sample size sufficient to determine the impact on the incidence of severe diarrhea and acute lower respiratory infection.


Condition or disease Intervention/treatment Phase
Diarrhea Pneumonia Acute Respiratory Tract Infection Drug: Zinc and vitamin A single dose at enrollment Drug: Placebo and vitamin A single dose at enrollment Not Applicable

Detailed Description:

Diarrheal disease is a major cause of child mortality in developing countries. Currently, the management of diarrhea focuses on oral rehydration therapy in acute diarrhea. However, acute diarrhea accounts for only 1/3 of the diarrhea-related deaths, the majority of the remaining being caused by persistent diarrhea. Currently persistent diarrhea treatment is complex, not yet adapted to community settings and, hence, has only a marginal impact on diarrheal mortality. A major challenge is to develop and implement cost-effective community-based interventions that can be applied to children with diarrhea to prevent persistence.

The trial was implemented in the urban slum of Dakshinpuri comprising 15,000 dwellings and a population of about 75,000. Recent data from a neighboring community indicated that childhood malnutrition, zinc deficiency, diarrhea and lower respiratory tract infection were common. Children aged 6 to 30 months were identified through a door-to-door survey. Enrollment required that the parents give informed consent and that families did not intend to emigrate. Eligible children were individually randomized by a simple randomization scheme in blocks of 8 generated by a person at Statens Serum Institut, Denmark. The zinc and placebo syrups were prepared and packaged in unbreakable bottles by GK Pharma Aps (Koge, Denmark( and labeled with unique child number according to the randomization scheme. The zinc and placebo syrups were similar in appearance, taste and packaging.

The enrolled children were randomized to receive zinc gluconate (10 mg elemental zinc/day to infants and 20 mg/day to older children) or placebo daily for a period of 4 months. All included subjects were given a massive dose of vitamin A at enrollment in addition to zinc or placebo. A field attendant administered the syrup daily at home for 4 months except on Sundays, when the mother was asked to administer it. One bottle containing 250 mL was kept in the child's home and replaced monthly.

Field workers visited households every seventh day during the 4-month follow-up period. At each visit, information was obtained for the previous 7 days on history of fever, number and consistency of stools. If the child had diarrhea or vomiting, dehydration was assessed. Information was also obtained on cough, lower chest indrawing and on their illness characteristics and whether treatment was sought in the previous 7 days. Intervention impact was assessed on physician-diagnosed acute lower respiratory tract infections and pneumonia.

Blood was collected at baseline in all children to measure micronutrient status. Cognitive development was measured at baseline and end study using Bayelys Scales of Infant Development version II.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2482 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Zinc and Vitamin A Supplementation on Diarrhea, Physical Growth and Immune Response in Malnourished Children
Study Start Date : February 1998
Actual Primary Completion Date : February 2000
Actual Study Completion Date : September 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea Vitamin A

Arm Intervention/treatment
Experimental: 1
10 mg/day of elemental zinc as zinc gluconate to infants and 20 mg/day to older children and Vitamin A 100,000 IU to infants and 200,000 IU to older children
Drug: Zinc and vitamin A single dose at enrollment
10 mg/day of elemental zinc as zinc gluconate to infants and 20 mg/day to older children

Placebo Comparator: 2 Drug: Placebo and vitamin A single dose at enrollment
Placebo was plain glucose. Vitamin A 100,000 IU to infants and 200,000 IU to older children




Primary Outcome Measures :
  1. - To measure the impact of zinc and vitamin A on the duration of diarrheal illness [ Time Frame: Weekly home visits for 6 months ]

Secondary Outcome Measures :
  1. - To measure the impact of supplementation on the outcome of acute diarrhea, particularly on the risk of persistence [ Time Frame: Weekly home visits for 6 months ]
  2. - To measure the impact of supplementation on immune response to parenteral live measles vaccine and oral live tetravalent rotavirus vaccine [ Time Frame: At baseline and end study ]
  3. To measure the impact of zinc and vitamin A on cognitive development [ Time Frame: 6 months ]
    Measure the efficacy of daily zinc administration on cognitive development in children 12 to 18 months of age.

  4. -To measure the prevalence of zinc, copper, folate, vitamin B12, vitamin D, vitamin A and vitamin E deficiencies in the included children [ Time Frame: 6 months ]
    From the plasma specimen collected at baseline, measure the concentration of various nutrients to estimate the prevalences of deficiency of these.

  5. -To measure the association between nutrient status at baseline (including micronutrient status) and subsequent diarrheal and respiratory illnesses [ Time Frame: 6 months ]
    Measure to what extent plasma levels of zinc, copper, folate, vitamin B12, vitamin D, vitamin A, and vitamin E predicts infections over the subsequent 4 months.

  6. -To measure the association between nutrient status at baseline (including micronutrient status) and cognitive development. [ Time Frame: 6 months ]
    We will measure to what extent, deficiencies of micronutrients predicts cognitive development in children 12 to 18 months of age.

  7. -To measure whether or not deficiencies of selected micronutrients modifies the effect of zinc on diarrhea or pneumonia [ Time Frame: 6 months ]
    From the analyses of vitamins and minerals in plasma, we will measure to what extent deficiencies of these modifies the effect of zinc on pneumonia and diarrhea.



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Ages Eligible for Study:   6 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children in the age group 6-30 months
  • Either sex

Exclusion Criteria:

  • Refused consent
  • Likely to move out of study area within the next four months
  • Urgent admission to hospital on the enrollment day
  • Had received massive dose of vitamin A within the two months before enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272116


Locations
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India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
Society for Applied Studies
European Commission
World Health Organization
Norwegian Council of Universities’ Committee for Development Research and Education
Investigators
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Principal Investigator: Maharaj K Bhan, MD All India Institute of Medical Sciences, New Delhi
Principal Investigator: Nita Bhandari, PhD Society for Applied Studies, New Delhi

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NBhandari, Director, Society for Applied Studies
ClinicalTrials.gov Identifier: NCT00272116     History of Changes
Other Study ID Numbers: ERB3514PL950371
IC18-CT96-0045
First Posted: January 4, 2006    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: April 2012
Keywords provided by NBhandari, Society for Applied Studies:
zinc
diarrhea
severe diarrhea
recurrent diarrhea
acute lower respiratory infection
pneumonia
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia
Diarrhea
Infection
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Vitamins
Vitamin A
Zinc
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents