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

NCT00272116 | Completed

• 2 other identifiers: ERB3514PL950371IC18-CT96-0045
• Study Type: interventional
• Target: 2,482
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Pneumonia; Acute Respiratory Tract Infection

Keywords

zinc; diarrhea; severe diarrhea; recurrent diarrhea; acute lower respiratory infection; pneumonia

Outcome Measures

Primary Outcomes (1)

• - To measure the impact of zinc and vitamin A on the duration of diarrheal illness

  Weekly home visits for 6 months

Secondary Outcomes (7)

• - To measure the impact of supplementation on the outcome of acute diarrhea, particularly on the risk of persistence

  Weekly home visits for 6 months

• - To measure the impact of supplementation on immune response to parenteral live measles vaccine and oral live tetravalent rotavirus vaccine

  At baseline and end study

• To measure the impact of zinc and vitamin A on cognitive development

  6 months

• -To measure the prevalence of zinc, copper, folate, vitamin B12, vitamin D, vitamin A and vitamin E deficiencies in the included children

  6 months

• -To measure the association between nutrient status at baseline (including micronutrient status) and subsequent diarrheal and respiratory illnesses

  6 months

Study Arms (2)

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

2

PLACEBO COMPARATOR

Drug: Placebo and vitamin A single dose at enrollment

Interventions

Zinc and vitamin A single dose at enrollment DRUG

10 mg/day of elemental zinc as zinc gluconate to infants and 20 mg/day to older children

1

Placebo and vitamin A single dose at enrollment DRUG

Placebo was plain glucose. Vitamin A 100,000 IU to infants and 200,000 IU to older children

2

Eligibility Criteria

• Age: 6 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Society for Applied Studies: lead
• European Commission: collaborator
• World Health Organization: collaborator
• Norwegian Council of Universities' Committee for Development Research and Education: collaborator

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (6)

• Bhandari N, Bahl R, Taneja S, Strand T, Molbak K, Ulvik RJ, Sommerfelt H, Bhan MK. Effect of routine zinc supplementation on pneumonia in children aged 6 months to 3 years: randomised controlled trial in an urban slum. BMJ. 2002 Jun 8;324(7350):1358. doi: 10.1136/bmj.324.7350.1358.

  PMID: 12052800 RESULT

• Bhandari N, Bahl R, Taneja S, Strand T, Molbak K, Ulvik RJ, Sommerfelt H, Bhan MK. Substantial reduction in severe diarrheal morbidity by daily zinc supplementation in young north Indian children. Pediatrics. 2002 Jun;109(6):e86. doi: 10.1542/peds.109.6.e86.

  PMID: 12042580 RESULT

• Strand TA, Taneja S, Ueland PM, Refsum H, Bahl R, Schneede J, Sommerfelt H, Bhandari N. Cobalamin and folate status predicts mental development scores in North Indian children 12-18 mo of age. Am J Clin Nutr. 2013 Feb;97(2):310-7. doi: 10.3945/ajcn.111.032268. Epub 2013 Jan 2.

  PMID: 23283502 DERIVED

• Manger MS, Taneja S, Strand TA, Ueland PM, Refsum H, Schneede J, Nygard O, Sommerfelt H, Bhandari N. Poor folate status predicts persistent diarrhea in 6- to 30-month-old north Indian children. J Nutr. 2011 Dec;141(12):2226-32. doi: 10.3945/jn.111.144220. Epub 2011 Oct 19.

  PMID: 22013199 DERIVED

• Manger MS, Strand TA, Taneja S, Refsum H, Ueland PM, Nygard O, Schneede J, Sommerfelt H, Bhandari N. Cobalamin status modifies the effect of zinc supplementation on the incidence of prolonged diarrhea in 6- to 30-month-old north Indian children. J Nutr. 2011 Jun;141(6):1108-13. doi: 10.3945/jn.110.127415. Epub 2011 Apr 27.

  PMID: 21525251 DERIVED

• Taneja S, Strand TA, Sommerfelt H, Bahl R, Bhandari N. Zinc supplementation for four months does not affect growth in young north Indian children. J Nutr. 2010 Mar;140(3):630-4. doi: 10.3945/jn.109.115766. Epub 2010 Jan 27.

  PMID: 20107146 DERIVED

MeSH Terms

Conditions

Diarrhea; Pneumonia

Interventions

Zinc; Vitamin A

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Maharaj K Bhan, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Nita Bhandari, PhD

  Society for Applied Studies, New Delhi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 2, 2006
• First Posted: January 4, 2006
• Study Start: February 1, 1998
• Primary Completion: February 1, 2000
• Study Completion: September 1, 2000
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

IN (1)