Effect on Iron Levels Clinical Trial
Official title:
Effect on Iron Levels by the Inclusion of Native Potato in the Diet of Children From 2 to 5 Years, ICBF Beneficiaries in the Municipalities of Carlosama, Cumbal, Guachucal, Túquerres y Pasto. Nariño. Colombia. Cluster Randomized Controlled Trial
| NCT number | NCT02160405 |
| Other study ID # | 74282013 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | May 8, 2014 |
| Last updated | June 6, 2014 |
| Start date | February 2014 |
| Verified date | June 2014 |
| Source | Universidad Nacional de Colombia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Colombia: Universidad Nacional de Colombia |
| Study type | Interventional |
Nutritional deficiencies can lead to a number of health problems in children. In Latin
America and the Caribbean countries, are registered so much problems of insufficient
ingestion of food as of imbalances in the composition of the diet. These latter are
expressed in the absence of micronutrients (iron, iodine, zinc, vitamin A), becoming a major
health burden in developing countries. Being the globally's leading risk factor for disease
and death, with hundreds of millions of pregnant women and young children particularly
affected.
Justification: In Nariño, Colombia higher levels of malnutrition are presented with respect
to country, just as micronutrient deficiency in children 1 to 4 years is higher than the
national average. Most of these households are poor families with restrictions on access to
food sources of these micronutrients, which is reported in a consumption of fruits,
vegetables, milk products and meat, less than the national average. In this place is
developing a project that aims to improve potato in higher yield, nutrition and resistance,
for contribute to increase food security of native communities.
Objective: Evaluate the effect on iron levels generated by the inclusion of native potato in
the diet of children aged 2-5 years in institutional beneficiaries modality ICBF, in the
municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto. Nariño. Colombia
Methods:
Design: A cluster randomized controlled trial. Open label Setting: 6 clusters,
municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto (two towns), which will
be randomly assigned to 2 groups: the treatment group that receives native potato, and the
control group that receives traditional potato, that will be include in the usual
Institution meal Participants: children from 2 to 5 years, beneficiaries of programs in
institutional modality of ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres,
Cumbal and Pasto.
Main outcome measures: serum ferritin and transferrin levels
The study was conducted in the form of institutional programs ICBF, in the municipalities of
Carlosama, Guachucal, Túquerres, Cumbal and Pasto. Colombia. One hypothesis to a queue based
on the changes that occur over time after surgery in the mean values (μ) of serum ferritin
in the treatment group compared with the control group. A sample size of 212 children were
calculated. The study has been presented and approved by the Ethics Committee of the Faculty
of Medicine of the National University of Colombia and the Institutional Review Board of the
participating institution. All parents of participating children must sign a written form to
accept the voluntary participation of their child in the study.
| Status | Completed |
| Enrollment | 212 |
| Est. completion date | |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 5 Years |
| Eligibility |
Inclusion Criteria: - children from 2 to 5 years, beneficiaries of programs in institutional modality of ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto Exclusion Criteria: - Children who met inclusion criteria but are not allowed to participate, refuse systematically to the test or don't go regularly to the institution |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Colombia | Centros de Desarrollo Infantil Institucional | Pasto | Nariño |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad Nacional de Colombia | McGill University, Trade and Development Canada and Canadian International Development Agency (CIDA) |
Colombia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Weight | 11 weeks | No | |
| Other | Height | Changes in Height over the time | 11 Weeks | No |
| Other | food intake | Changes in food intake in the period | 11 Weeks | No |
| Other | supplement of micronutrient | 11 Weeks | No | |
| Primary | serum ferritin leves | 11 Weeks | No | |
| Primary | Serum transferrin levels | 11 weeks | No | |
| Secondary | Haemoglobin | 11 Weeks | No |