Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children

This study has been completed.
Sponsor:
Collaborators:
Université Polytechnique de Bobo-Dioulasso
Helen Keller International
Thrasher Research Fund
Canadian International Development Agency
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00944359
First received: July 21, 2009
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to determine how best to integrate programs designed either to prevent zinc deficiency or to treat diarrhea.

The overall objective of this project is to determine the most effective approach to prevent zinc deficiency and treat diarrhea, such that a single approach could provide the maximal beneficial impact on the health and nutritional status of young children and greatest simplicity of implementation.


Condition Intervention Phase
Zinc Deficiency
Diarrhea
Malaria
Dietary Supplement: Daily preventive Zn; placebo treatment
Dietary Supplement: Therapeutic Zn; daily placebo
Dietary Supplement: Intermittent Zn; placebo treatment
Other: Surveillance control group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Change in length and length-for-age Z-score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in weight and weight-for-age [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of diarrhea and laboratory-confirmed malaria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in plasma zinc concentration [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of stunting, underweight, and wasting [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in hemoglobin and iron status [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 7680
Study Start Date: December 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daily preventive Zn; placebo treatment
7 mg zinc per day for 12 months and placebo supplement during diarrhea episode
Dietary Supplement: Daily preventive Zn; placebo treatment
7 mg zinc / day and placebo supplement during diarrhea episodes
Other Name: Nutriset preventive zinc and therapeutic placebo supplement
Experimental: Therapeutic Zn; daily placebo
20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement
Dietary Supplement: Therapeutic Zn; daily placebo
20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement
Other Name: Nutriset ZinCfant
Experimental: Intermittent Zn; placebo treatment
10 mg zinc for 10 days every 3 months, daily placebo during 80 days of 3 months period and placebo during diarrhea episode
Dietary Supplement: Intermittent Zn; placebo treatment
10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes
Other Name: Nutriset zinc supplement
Active Comparator: Surveillance control group
Surveillance control group will be randomly assigned to intervention groups every 3 months
Other: Surveillance control group
Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months
No Intervention: Non-intervention
Standard care provided by health system

Detailed Description:

This is a single-center cluster- and household-randomized, partially masked, community-based efficacy trial of zinc supplementation. The study sample consists of 5 study groups in one region, with 34 clusters randomly assigned to 3 types of intervention communities.

Communities will be randomly assigned to 1) early intervention communities, 2) later intervention communities, 3) non-intervention communities. Within each intervention cluster, children will be randomly assigned to the intervention group at the household level. Children aged 6-27 months at enrollment will be eligible. The study duration is 12 months.

The investigators will assess the relative impact of daily preventive zinc supplementation (7 mg zinc/d for one year), intermittent preventive supplementation (10 mg zinc/d for 10 days every three months for one year), and zinc treatment during episodes of diarrhea (20 mg zinc/d for 10 days beginning with each episode of diarrhea during one year). Outcomes that will be assessed include the incidence and duration of all episodes of diarrhea, the incidence of malaria, physical growth, and (in a sub-group) biochemical indicators of zinc, iron and vitamin A status.

  Eligibility

Ages Eligible for Study:   6 Months to 27 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 6-27 months of age
  • Plan to remain in study area for 1 year

Exclusion Criteria:

  • Evidence of congenital abnormalities and chronic infection
  • Severe anemia and severe acute malnutrition
  • Consumption of micronutrient supplementation including zinc
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944359

Locations
Burkina Faso
Institut de Recherche en Science de la Sante
Bobo-Dioulasso, Burkina Faso
Sponsors and Collaborators
University of California, Davis
Université Polytechnique de Bobo-Dioulasso
Helen Keller International
Thrasher Research Fund
Canadian International Development Agency
Investigators
Principal Investigator: Kenneth H Brown, MD University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00944359     History of Changes
Other Study ID Numbers: 222218, Zinc 7-20
Study First Received: July 21, 2009
Last Updated: December 7, 2012
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by University of California, Davis:
zinc supplementation
diarrhea management
zinc deficiency
malaria

Additional relevant MeSH terms:
Malaria
Diarrhea
Protozoan Infections
Parasitic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014