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ISRCTN
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ISRCTN39244429
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ClinicalTrials.gov identifier
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Public title
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Nutritional supplement sprinkles with zinc and micronutrients
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Scientific title
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Efficacy of the nutritional supplement sprinkles with zinc and micronutrients on anaemia and acute diarrhoea in Peruvian children
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Acronym
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SUNSZIM
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Serial number at source
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IIN-270
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Study hypothesis
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1. Children 6 to 17 months of age that consume the nutritional supplement sprinkles with zinc and micronutrients for a 6 month period will have a lower prevalence of anaemia than will those children that consume the nutritional supplement sprinkles with iron alone.
2. Children 6 to 17 months of age that consume the nutritional supplement sprinkles with zinc and micronutrients for a 6 month period will have a lower incidence and prevalence of acute diarrhoea than will those children that consume the nutritional supplement sprinkles with iron alone.
3. Children 6 to 17 months of age that consume the nutritional supplement sprinkles with zinc and micronutrients for a 6 month period will have better growth than those children that consume the nutritional supplement sprinkles with iron alone.
4. The adherence of the nutritional supplement sprinkles with zinc and micronutrients and the nutritional supplement sprinkles with iron alone will be similar, in both cases greater than 75% of the offered doses.
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Lay summary
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Ethics approval
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1. Instituto de Investigacion Nutricional (IIN) Institutional Review Board (IRB) approved on the 26th of June 2009 (ref: 284-2009/CEI-IIN)
2. Mount Sinai Hospital IRB approved on the 22nd of October 2009
3. Peruvian NIH authorisation received on the 18th of September 2009
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Study design
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Interventional single centre phase III double blind randomised controlled trial
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Countries of recruitment
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Peru
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Disease/condition/study domain
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Anaemia and diarrhoea
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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07/01/2010
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Anticipated end date
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31/01/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet (in Spanish)
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Target number of participants
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902
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Interventions
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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 encapsulated to prevent changing the taste, texture, or colour of the food. The composition used in this study is outlined in the table below.
Micronutrient Amount
Iron as fumarate 12.5mg
Zinc as gluconate 10 mg
Folic Acid 160mcg
Vitamin A 300mcg RE
Vitamin C 30mg
Control Product:
The control group is also a powdered sprinkles form having the following composition per sachet.
Micronutrients Quantity
Iron as fumarate 12.5mg
Route of administration (both groups): Oral
Presentation Form: Powder
Duration of supplementation per subject: 6 months.
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Primary outcome measure(s)
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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 outcome measure(s)
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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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Sources of funding
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United Nations Children's Fund (UNICEF) (USA)
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Trial website
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Publications
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Contact name
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Dr
Nelly
Zavaleta
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Address
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Av. La Molina 1885
La Molina
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City/town
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Lima
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Zip/Postcode
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Lima 12
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Country
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Peru
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Sponsor
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Instituto de Investigación Nutricional (IIN) (Peru)
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Address
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Av. La Molina 1885
La Molina
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City/town
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Lima
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Zip/Postcode
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Lima 12
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Country
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Peru
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Date applied
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12/02/2010
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Last edited
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15/03/2011
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Date ISRCTN assigned
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16/03/2010
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