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

ISRCTN

Registry ID

ISRCTN39244429

Enrollment

902

Registered

2010-03-16

Start date

2010-01-07

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Anaemia and diarrhoea Nutritional, Metabolic, Endocrine

Interventions

Research product: Micronutrient supplement as sprinkles, packaged into individual sachets, each sachet intended for once daily use to be mixed with food. The iron portion of the powder is lipid encap

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 6 months and 17 months, 29 days of age 2. Residents of Villa El Salvador, Lima, Peru 3. Born at term 4. Birth weight equal or higher than 2500g 5. Healthy 6. Parents agree to sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Age less than 6 months, or equal to/greater than 18 months 2. Not residents in the area of intervention 3. 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 4. Weight/Length less than -2 Standard Deviations (SD) 5. Any chronic, congenital, or severe illnesses 6. Children that regularly consume other micronutrient supplements

Design outcomes

Primary

Measure	Time frame
1. Anemia: 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. 2. Diarrhoea: Morbidity is recorded by home surveillance once a week and we register the daily morbidity, prevalence of diarrhoea is registered as the days with morbidity over the number of observation days x 100, incidence as number of episodes of diarrhoea per 100 days of observations.	—

Measure

Time frame

1. Anemia: 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. 2. Diarrhoea: Morbidity is recorded by home surveillance once a week and we register the daily morbidity, prevalence of diarrhoea is registered as the days with morbidity over the number of observation days x 100, incidence as number of episodes of diarrhoea per 100 days of observations.

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Secondary

Measure	Time frame
1. Incidence of severe diarrhoea: 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. 2. Duration of diarrhoea: Number of days with diarrhoea ( = 3 liquid or loose stools in the last 24 hr). 3. Adherence to supplementation: Number of sachets consumed during the study per over the number of sachets given x 100. 4. Changes in weight and length: 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. 5. Serum zinc: Measured at entry and 6 months post supplementation.	—

Measure

Time frame

1. Incidence of severe diarrhoea: 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. 2. Duration of diarrhoea: Number of days with diarrhoea ( = 3 liquid or loose stools in the last 24 hr). 3. Adherence to supplementation: Number of sachets consumed during the study per over the number of sachets given x 100. 4. Changes in weight and length: 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. 5. Serum zinc: Measured at entry and 6 months post supplementation.

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Countries

Peru

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026