Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children

University of California (UC) Davis

Status: Completed

Conditions: Diarrhea; Malaria; Zinc Deficiency

Treatments: Dietary Supplement: Therapeutic Zn; daily placebo; Dietary Supplement: Daily preventive Zn; placebo treatment; Dietary Supplement: Intermittent Zn; placebo treatment; Other: Surveillance control group

Study type: Interventional

Funder types: Other

Identifiers

NCT00944359

222218

Zinc 7-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,680 patients

Sex: All

Ages: 6 to 27 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7,680 participants in 5 patient groups

Daily preventive Zn; placebo treatment

Experimental group

Description:

7 mg zinc per day for 12 months and placebo supplement during diarrhea episode

Treatment:

Dietary Supplement: Daily preventive Zn; placebo treatment

Therapeutic Zn; daily placebo

Experimental group

Description:

20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement

Treatment:

Dietary Supplement: Therapeutic Zn; daily placebo

Intermittent Zn; placebo treatment

Experimental group

Description:

10 mg zinc for 10 days every 3 months, daily placebo during 80 days of 3 months period and placebo during diarrhea episode

Treatment:

Dietary Supplement: Intermittent Zn; placebo treatment

Surveillance control group

Active Comparator group

Description:

Surveillance control group will be randomly assigned to intervention groups every 3 months

Treatment:

Other: Surveillance control group

Non-intervention

No Intervention group

Description:

Standard care provided by health system