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Nutritional supplement sprinkles with zinc and micronutrients

Efficacy of the nutritional supplement sprinkles with zinc and micronutrients on anaemia and acute diarrhoea in Peruvian children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-078-09
Enrollment
902
Registered
2009-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1 Type of group
Nutritional supplement sprinkies with zinc and micronutrients: Iron as fumarate 12.5mg, Zinc as zinc oxide 10mg, Folic acid 160mcg, Vitamin A as retinol palmltate 300mcg RE, Vitamin C as ascorbic acid 30mg Group name:Group 2 Type of group
Nutritional supplement sprinkles with iron (control group), which contains 12.5 mg of iron as ferrous fumarate

Sponsors

UNICEF,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 17 Years

Inclusion criteria

Inclusion criteria: • Aged between 6 months and 17 months, 29 days of age • Residents of Villa El Salvador, Lima, Peru • Born at term • Birth weight equal or higher than 2500g • Healthy • Parents agree to sign the informed consent form

Exclusion criteria

Exclusion criteria: • Age less than 6 months, or equal to/greater than 18 months • Not residents in the area of intervention • Children with an initial haemoglobin equal to or less than 8g/dL will be evaluated by a doctor to rule out some additional pathology and will receive treatment according to Peruvian Ministry of Health (Ministerio de Salud [MINSA]) norms • Weight/Length less than -2 Standard Deviations (SD) • Any chronic, congenital, or severe illnesses • Children that regularly consume other micronutrient supplements

Design outcomes

Primary

MeasureTime frame
Outcome name:Haemoglobin (Hb) is measured by HemoCue® at baseline and 6 months later (end of the study participation). Prevalence of anaemia is the percentage of children with Hb below 11 g/dl (WHO definition). We will also compare mean Hb values at baseline and end of the study. Measure:Variation of Haemoglobin values Timepoints:6 months

Secondary

MeasureTime frame
Outcome name:Number of days with diarrhoea ( ≥ 3 liquid or loose stools in the last 24 hr). Measure:Duration of diarrhoea Timepoints:During the study ; Outcome name:Number of sachets consumed during the study per over the number of sachets given x 100. Measure:Adherence to supplementation Timepoints:During the study ; Outcome name:Anthropometric measures weight and length will be taken on infants at baseline and monthly through 6 months of intervention, and Z scores determined for weight-for-age (WAZ), length-for-age (LAZ), and weight-for-length (WLZ) compared to WHO references. Measure:Changes in weight and length Timepoints:During the study ; Outcome name:Measured at entry and 6 months post supplementation. Measure:Serum zinc Timepoints:During the study ; Outcome name:Severe diarrhoea is defined as ≥ 6 liquid or loose stools in the last 24 hr, number of episodes of severe diarrhoea per 100 days of observations. Measure:Incidence of severe diarrhoea Timepoints:During the study

Countries

Peru

Contacts

Public ContactNelly Mercedes Zavaleta

INSTITUTO DE INVESTIGACION NUTRICIONAL

nzavalet@iin.sld.pe3496023

Outcome results

None listed

Source: REPEC (via WHO ICTRP)