Nutritional supplement sprinkles with zinc and micronutrients
| ISRCTN | ISRCTN39244429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39244429 |
| Secondary identifying numbers | IIN-270 |
- Submission date
- 12/02/2010
- Registration date
- 16/03/2010
- Last edited
- 15/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Nelly Zavaleta
Scientific
Scientific
Av. La Molina 1885
La Molina
Lima
Lima 12
Peru
Study information
| Study design | Interventional single centre phase III double blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet (in Spanish) |
| Scientific title | Efficacy of the nutritional supplement sprinkles with zinc and micronutrients on anaemia and acute diarrhoea in Peruvian children |
| Study acronym | SUNSZIM |
| Study hypothesis | 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. |
| Ethics approval(s) | 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 |
| Condition | Anaemia and diarrhoea |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 07/01/2010 |
| Overall study end date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 17 Months |
| Sex | Both |
| Target number of participants | 902 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 07/01/2010 |
| Recruitment end date | 31/01/2011 |
Locations
Countries of recruitment
- Peru
Study participating centre
Av. La Molina 1885
Lima
Lima 12
Peru
Lima 12
Peru
Sponsor information
Instituto de Investigación Nutricional (IIN) (Peru)
Research organisation
Research organisation
Av. La Molina 1885
La Molina
Lima
Lima 12
Peru
"ROR" |
https://ror.org/05by4rq81 |
|---|
Funders
Funder type
Charity
United Nations Children's Fund (UNICEF) (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
