Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Society for Applied Studies European Commission World Health Organization Norwegian Council of Universities’ Committee for Development Research and Education |
---|---|
Information provided by: | Society for Applied Studies |
ClinicalTrials.gov Identifier: | NCT00272116 |
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 | Intervention |
---|---|
Diarrhea Pneumonia Acute Respiratory Tract Infection |
Drug: Zinc and vitamin A single dose at enrollment Drug: Placebo and vitamin A single dose at enrollment |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Effect of Zinc and Vitamin A Supplementation on Diarrhea, Physical Growth and Immune Response in Malnourished Children |
Enrollment: | 2482 |
Study Start Date: | February 1998 |
Study Completion Date: | September 2000 |
Primary Completion Date: | February 2000 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
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
|
2: Placebo Comparator |
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
|
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.
Ages Eligible for Study: | 6 Months to 30 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
India, Delhi | |
All India Institute of Medical Sciences | |
New Delhi, Delhi, India, 110029 |
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 |
Responsible Party: | All India Institute of Medical Sciences ( Dr. MK Bhan ) |
Study ID Numbers: | ERB3514PL950371, IC18-CT96-0045 |
Study First Received: | January 2, 2006 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00272116 History of Changes |
Health Authority: | India: Ministry of Health |
zinc diarrhea severe diarrhea |
recurrent diarrhea acute lower respiratory infection pneumonia |
Retinol Anticarcinogenic Agents Antioxidants Diarrhea Signs and Symptoms, Digestive Trace Elements Recurrence Signs and Symptoms Malnutrition |
Respiratory Tract Infections Respiratory Tract Diseases Retinol palmitate Lung Diseases Vitamins Vitamin A Zinc Micronutrients Pneumonia |
Anticarcinogenic Agents Antioxidants Diarrhea Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Antineoplastic Agents Growth Substances Physiological Effects of Drugs Trace Elements Infection Protective Agents Pharmacologic Actions |
Signs and Symptoms Respiratory Tract Infections Respiratory Tract Diseases Retinol palmitate Therapeutic Uses Lung Diseases Vitamin A Vitamins Zinc Micronutrients Pneumonia |