HemoglobinNCT03313089
Nutritional Impact of a Project on Food Security and Nutrition in Children Receiving Micronutrient Powders in Colombia
An observational study of Hemoglobin and Anemia, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial summary
The effectiveness of micronutrient powders or MNP as a strategy for the prevention of micronutrient deficiencies has been described in the literature. However, few studies have shown the impact of the inclusion of other simultaneous actions on the different dimensions of food and nutritional security (as in the case… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Hemoglobin, Anemia
- What is being tested?
- "Papas más nutritivas" (PSAN)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 112 participants
- Where
- 1 siteColombia
- Study dates
- 7 Jul 2017to 26 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- Child
Study population: Boys and girls of 6 months to 5 years of age inhabitants of municipalities: Carlosama, Guachucal, Túquerres and Cumbal in the department of Nariño,
Who may be able to join
- Boys and girls of 6 months to 5 years of age receiving home fortification with micronutrient powders.
Who cannot join
- Children who are consuming nutritional complements or supplements.
- Children undergoing treatment for anemia or other micronutrient deficiencies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Impact of a Project on Food Security and Nutrition in Children of 6 Months to 5 Years of Age Receiving Home Fortification With Micronutrient Powders in Nariño, Colombia
The effectiveness of micronutrient powders or MNP as a strategy for the prevention of micronutrient deficiencies has been described in the literature. However, few studies have shown the impact of the inclusion of other simultaneous actions on the different dimensions of food and nutritional security (as in the case of the project "Papas más nutritivas") that will contribute to the improvement of nutritional status, obtaining potentially greater benefits.
The objective is to establish the existence of difference in hemoglobin values (and other biochemical parameters as secondary outcomes) among children aged 6 months to 5 years who receive home fortification with micronutrient powders (MNP) belonging to the project "Papas más nutritivas", and children with home fortification with MNP but not belonging to the project.
Read the detailed description
Micronutrient deficiency is a public health problem. At the national level according to ENSIN 2010, in Colombia the prevalence of anemia in children of 6 to 59 months is 27.5%; of 24.3% for vitamin A deficiency in children between 1 and 4 years of age; and in the case of zinc deficiency, the prevalence is of 43.3% of children under 5 years of age. According to FAO and WHO, different strategies for overcoming micronutrient deficiencies need to be combined and balanced in order to achieve maximum impact.
The project "Papas más nutritivas" ("Ampliación de la producción de papas amarillas más nutritivas en Colombia (CIFSRF phase 2) / Scaling up synergetic strategies in agriculture and nutrition in rural communities of Colombia") funded by the IDRC-International Development Research Center, through the Canadian International Food Security Research Fund (CISFR) and implemented by the McGILL University Canada and the Universidad Nacional de Colombia involve, in addition to the expansion of production of the new varieties of yellow potatoes, other activities such as Community Schools of Family Agriculture, training schools of leader and managers in sovereignty and food and nutritional security, strengthening of the shagra (home garden) and home fortification with micronutrients powders, seeking to improve the quality of life and nutritional status of families of potato producers for the scope of the food and nutritional security.
The effectiveness of micronutrient powders or MNP as a strategy for the prevention of micronutrient deficiencies has been described in the literature. However, few studies have shown the impact of the inclusion of other simultaneous actions on the different dimensions of food and nutritional security (as in the case of the project "Papas más nutritivas") that will contribute to the improvement of nutritional status, obtaining potentially greater benefits.
Objective: To establish the existence of difference in hemoglobin values among children aged 6 months to 5 years who receive home fortification with micronutrient powders (MNP) belonging to the project "Papas más nutritivas", and children with home fortification with MNP but not belonging to the project.
Methodology: Prospective cohort. Two groups are established: the first, children exposed to the activities of the project "Papas más nutritivas" + MNP (PSAN+MNP group) , and the second, children exposed only to MNP (MNP group). We will try to include 140 children (70 for each of the groups), this sample gives us a power of 90% to find a delta of 0.5.
Blood samples will be obtained to evaluate the biochemical parameters: Hemoglobin (determined by HemoCue), Ferritin, Transferrin, Zinc, vitamin A, C-reactive-ultrasensitive protein, before MNP fortification and when it finished.
For statistical analysis, a descriptive analysis of both PSAN + MNP and MNP groups will be carried out on sociodemographic variables, health status and nutritional status. The continuous variables will be expressed with their measures of central tendency and dispersion, for the categorical variables absolute and relative frequencies will be used. The hypothesis of equality of pre and post treatment hemoglobin differences between the groups (PSAN + MNP versus MNP) will be analyzed using a Student t test or Mann Whitney test, depending on whether the data follow a normal distribution. A statistically significant p value corresponding to 0.05 will be considered. The other secondary outcome variables (vitamin A, zinc, ferritin, transferrin) will be similarly analyzed. In order to control the systematic differences in the baseline characteristics between the intervention and control groups, it is proposed to use Propensity Score, which will include the variables of sex, age and other sociodemographic and nutritional variables considered potentially confusing. The score of the propensity score model will be used as a covariate in a linear regression model where it will be adjusted further by the pre-test values of the intervention (ANCOVA). An unadjusted preliminary analysis (initially described) will be presented and then a new analysis with the proposed adjustment. An additional analysis will be performed for the ferritin variable excluding patients with high CRP values.
- Conditions
- Hemoglobin, Anemia
- Being tested
- "Papas más nutritivas" (PSAN)
- Keywords
- micronutrient powders, spinkles, nutrition, food security program, nutritional program, hemoglobin, anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Papas más nutritivas" (PSAN)Behavioural
Activities of the project "Papas más nutritivas"
| Study group | Role | What they receive |
|---|---|---|
| PSAN + MNP | PSAN ("Papas más nutritivas" project) + MNP (micronutrients powders):
Children of the families beneficiaries of Community Schools of Family Agriculture of the municipalities of Cumbal, Carlosama Guachucal and Túquerres, who are part of the project "Papas más nutritivas" and exposed to project activities in which they work on topics related to food and nutritional security, equity and gender, production and entrepreneurship, Additionally, the home fortification with MNP that is 12 months in total approximately, will be made 2 deliveries of 60 doses (specified in the "MNP only" group). After the delivery of MNP, advising, measurements of weight and height, clarification of doubts regarding fortification with MNP, nutrition education, and accompaniment by the project staff will take place. Receives: Behavioral: "Papas más nutritivas" (PSAN) | |
| MNP only | Cohort of exposed to MNP (micronutrients powders): Children who will receive MNP delivered through the hospital or institutional health service providers of the municipalities of Guachucal and Carlosama, following the protocol for the home fortification with MNP that is 12 months in total approximately, will be made 2 deliveries of 60 doses: the first period consists of the taking of MNP for 2 months, followed by a rest period of 4 months and continues again by another MNP intake for 2 months and rest for 4 months, and exposed to dissemination of basic information with regard to MNP and monitoring by growth and development that is routinely performed by health staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin concentration
g/dL
Measured: Baseline and after 12 months approximately
Secondary outcomes (4)
Vitamin A (change in serum retinol concentration)
μg / dL
Measured: Baseline and after 12 months approximately
Change in zinc concentration
μg / dL
Measured: Baseline and after 12 months approximately
Change in transferrin concentration
mg / dL
Measured: Baseline and after 12 months approximately
Change in ferritin concentration
μg / L
Measured: Baseline and after 12 months approximately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start7 Jul 2017
- Primary completion26 Nov 2017
- Study completion26 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for HemoglobinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- International Development Research Centre, Canada, McGill University
- Responsible party
- Principal investigator, Nathalie Ospina, Universidad Nacional de Colombia
- Investigators
- Sara E. Del Castillo Matamoros, Professor, Study director, Universidad Nacional de ColombiaJavier H. Eslava Schmalbach, Professor, Study director, Universidad Nacional de ColombiaNathalie Ospina Lizarazo, Student, Principal investigator, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313089
- Sponsor's protocol ID
- 37460
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ministerio De Salud y Protección Social. Estrategia Nacional para la Prevención y Control de las Deficiencias de Micronutrientes en Colombia 2014 - 2021. Bogotá D.C., Colombia. 2015.
World Health Organization and Food and Agriculture Organization of the United Nations. Guidelines on Food Fortification with Micronutrients. Editado por Lindsay Allen y cols.
Black R. Micronutrient deficiency--an underlying cause of morbidity and mortality. Bull World Health Organ. 2003;81(2):79. Epub 2003 Mar 25. No abstract available.
PubMed 12751414Ministerio de la Protección Social. Instituto Colombiano de Bienestar Familiar. ENSIN 2010- Encuesta Nacional de Situación Nutricional en Colombia 2010. Ed. Bogotá: 2011.
OMS. Directriz: Uso de micronutrientes en polvo para la fortificación domiciliaria de los alimentos consumidos por lactantes y niños de 6 a 23 meses de edad. Ginebra, Organización Mundial de la Salud, 2012.
Zlotkin SH, Schauer C, Christofides A, Sharieff W, Tondeur MC, Hyder SM. Micronutrient sprinkles to control childhood anaemia. PLoS Med. 2005 Jan;2(1):e1. doi: 10.1371/journal.pmed.0020001.
PubMed 15696200De-Regil LM, Suchdev PS, Vist GE, Walleser S, Pena-Rosas JP. Home fortification of foods with multiple micronutrient powders for health and nutrition in children under two years of age. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008959. doi: 10.1002/14651858.CD008959.pub2.
PubMed 21901727Hotz C, Pelto G, Armar-Klemesu M, Ferguson EF, Chege P, Musinguzi E. Constraints and opportunities for implementing nutrition-specific, agricultural and market-based approaches to improve nutrient intake adequacy among infants and young children in two regions of rural Kenya. Matern Child Nutr. 2015 Dec;11 Suppl 3(Suppl 3):39-54. doi: 10.1111/mcn.12245.
PubMed 26778801Inayati DA, Scherbaum V, Purwestri RC, Wirawan NN, Suryantan J, Hartono S, Bloem MA, Pangaribuan RV, Biesalski HK, Hoffmann V, Bellows AC. Combined intensive nutrition education and micronutrient powder supplementation improved nutritional status of mildly wasted children on Nias Island, Indonesia. Asia Pac J Clin Nutr. 2012;21(3):361-73.
PubMed 22705425Attanasio OP, Fernandez C, Fitzsimons EO, Grantham-McGregor SM, Meghir C, Rubio-Codina M. Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial. BMJ. 2014 Sep 29;349:g5785. doi: 10.1136/bmj.g5785.
PubMed 25266222Andrew A, Attanasio O, Fitzsimons E, Rubio-Codina M. Why is multiple micronutrient powder ineffective at reducing anaemia among 12-24 month olds in Colombia? Evidence from a randomised controlled trial. SSM Popul Health. 2016 Mar 7;2:95-104. doi: 10.1016/j.ssmph.2016.02.004. eCollection 2016 Dec.
PubMed 29349132Jack SJ, Ou K, Chea M, Chhin L, Devenish R, Dunbar M, Eang C, Hou K, Ly S, Khin M, Prak S, Reach R, Talukder A, Tokmoh LO, Leon de la Barra S, Hill PC, Herbison P, Gibson RS. Effect of micronutrient sprinkles on reducing anemia: a cluster-randomized effectiveness trial. Arch Pediatr Adolesc Med. 2012 Sep;166(9):842-50. doi: 10.1001/archpediatrics.2012.1003.
PubMed 22801933Aboud FE, Akhter S. A cluster-randomized evaluation of a responsive stimulation and feeding intervention in bangladesh. Pediatrics. 2011 May;127(5):e1191-7. doi: 10.1542/peds.2010-2160. Epub 2011 Apr 18.
PubMed 21502222Avula R, Frongillo EA, Arabi M, Sharma S, Schultink W. Enhancements to nutrition program in Indian integrated child development services increased growth and energy intake of children. J Nutr. 2011 Apr 1;141(4):680-4. doi: 10.3945/jn.109.116954. Epub 2011 Feb 23.
PubMed 21346106Osei AK, Pandey P, Spiro D, Adhikari D, Haselow N, De Morais C, Davis D. Adding multiple micronutrient powders to a homestead food production programme yields marginally significant benefit on anaemia reduction among young children in Nepal. Matern Child Nutr. 2015 Dec;11 Suppl 4(Suppl 4):188-202. doi: 10.1111/mcn.12173.
PubMed 25682798
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Impact of a Project on Food Security and Nutrition in Children of 6 Months to 5 Years of Age Receiving Home Fortification With Micronutrient Powders in Nariño, Colombia
- ClinicalTrials.gov ID
- NCT03313089
- Acronym / sponsor ID
- 37460
- Conditions
- Hemoglobin, Anemia
- Keywords
- micronutrient powders, spinkles, nutrition, food security program, nutritional program, hemoglobin, anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Collaborators
- International Development Research Centre, Canada, McGill University
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 26 Nov 2017 (actual)
- Study completion
- 26 Nov 2017 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effectiveness of micronutrient powders or MNP as a strategy for the prevention of micronutrient deficiencies has been described in the literature. However, few studies have shown the impact of the inclusion of other simultaneous actions on the different dimensions of food and nutritional security (as in the case of the project "Papas más nutritivas") that will contribute to the improvement of nutritional status, obtaining potentially greater benefits.
The objective is to establish the existence of difference in hemoglobin values (and other biochemical parameters as secondary outcomes) among children aged 6 months to 5 years who receive home fortification with micronutrient powders (MNP) belonging to the project "Papas más nutritivas", and children with home fortification with MNP but not belonging to the project.
Detailed description
Micronutrient deficiency is a public health problem. At the national level according to ENSIN 2010, in Colombia the prevalence of anemia in children of 6 to 59 months is 27.5%; of 24.3% for vitamin A deficiency in children between 1 and 4 years of age; and in the case of zinc deficiency, the prevalence is of 43.3% of children under 5 years of age. According to FAO and WHO, different strategies for overcoming micronutrient deficiencies need to be combined and balanced in order to achieve maximum impact.
The project "Papas más nutritivas" ("Ampliación de la producción de papas amarillas más nutritivas en Colombia (CIFSRF phase 2) / Scaling up synergetic strategies in agriculture and nutrition in rural communities of Colombia") funded by the IDRC-International Development Research Center, through the Canadian International Food Security Research Fund (CISFR) and implemented by the McGILL University Canada and the Universidad Nacional de Colombia involve, in addition to the expansion of production of the new varieties of yellow potatoes, other activities such as Community Schools of Family Agriculture, training schools of leader and managers in sovereignty and food and nutritional security, strengthening of the shagra (home garden) and home fortification with micronutrients powders, seeking to improve the quality of life and nutritional status of families of potato producers for the scope of the food and nutritional security.
The effectiveness of micronutrient powders or MNP as a strategy for the prevention of micronutrient deficiencies has been described in the literature. However, few studies have shown the impact of the inclusion of other simultaneous actions on the different dimensions of food and nutritional security (as in the case of the project "Papas más nutritivas") that will contribute to the improvement of nutritional status, obtaining potentially greater benefits.
Objective: To establish the existence of difference in hemoglobin values among children aged 6 months to 5 years who receive home fortification with micronutrient powders (MNP) belonging to the project "Papas más nutritivas", and children with home fortification with MNP but not belonging to the project.
Methodology: Prospective cohort. Two groups are established: the first, children exposed to the activities of the project "Papas más nutritivas" + MNP (PSAN+MNP group) , and the second, children exposed only to MNP (MNP group). We will try to include 140 children (70 for each of the groups), this sample gives us a power of 90% to find a delta of 0.5.
Blood samples will be obtained to evaluate the biochemical parameters: Hemoglobin (determined by HemoCue), Ferritin, Transferrin, Zinc, vitamin A, C-reactive-ultrasensitive protein, before MNP fortification and when it finished.
For statistical analysis, a descriptive analysis of both PSAN + MNP and MNP groups will be carried out on sociodemographic variables, health status and nutritional status. The continuous variables will be expressed with their measures of central tendency and dispersion, for the categorical variables absolute and relative frequencies will be used. The hypothesis of equality of pre and post treatment hemoglobin differences between the groups (PSAN + MNP versus MNP) will be analyzed using a Student t test or Mann Whitney test, depending on whether the data follow a normal distribution. A statistically significant p value corresponding to 0.05 will be considered. The other secondary outcome variables (vitamin A, zinc, ferritin, transferrin) will be similarly analyzed. In order to control the systematic differences in the baseline characteristics between the intervention and control groups, it is proposed to use Propensity Score, which will include the variables of sex, age and other sociodemographic and nutritional variables considered potentially confusing. The score of the propensity score model will be used as a covariate in a linear regression model where it will be adjusted further by the pre-test values of the intervention (ANCOVA). An unadjusted preliminary analysis (initially described) will be presented and then a new analysis with the proposed adjustment. An additional analysis will be performed for the ferritin variable excluding patients with high CRP values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSAN + MNP | – | Behavioral: "Papas más nutritivas" (PSAN)PSAN ("Papas más nutritivas" project) + MNP (micronutrients powders): Children of the families beneficiaries of Community Schools of Family Agriculture of the municipalities of Cumbal, Carlosama Guachucal and Túquerres, who are part of the project "Papas más nutritivas" and exposed to project activities in which they work on topics related to food and nutritional security, equity and gender, production and entrepreneurship, Additionally, the home fortification with MNP that is 12 months in total approximately, will be made 2 deliveries of 60 doses (specified in the "MNP only" group). After the delivery of MNP, advising, measurements of weight and height, clarification of doubts regarding fortification with MNP, nutrition education, and accompaniment by the project staff will take place. |
| MNP only | – | –Cohort of exposed to MNP (micronutrients powders): Children who will receive MNP delivered through the hospital or institutional health service providers of the municipalities of Guachucal and Carlosama, following the protocol for the home fortification with MNP that is 12 months in total approximately, will be made 2 deliveries of 60 doses: the first period consists of the taking of MNP for 2 months, followed by a rest period of 4 months and continues again by another MNP intake for 2 months and rest for 4 months, and exposed to dissemination of basic information with regard to MNP and monitoring by growth and development that is routinely performed by health staff. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- Boys and girls of 6 months to 5 years of age inhabitants of municipalities: Carlosama, Guachucal, Túquerres and Cumbal in the department of Nariño,
Key inclusion criteria (1 listed)
- Boys and girls of 6 months to 5 years of age receiving home fortification with micronutrient powders.
Key exclusion criteria (2 listed)
- Children who are consuming nutritional complements or supplements.
- Children undergoing treatment for anemia or other micronutrient deficiencies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Papas más nutritivas" (PSAN)Activities of the project "Papas más nutritivas" | Behavioural | PSAN + MNP |
Primary outcome
Change in hemoglobin concentration
Time frame: Baseline and after 12 months approximately
g/dL
4 secondary outcomes
Vitamin A (change in serum retinol concentration)
Time frame: Baseline and after 12 months approximately
Change in zinc concentration
Time frame: Baseline and after 12 months approximately
Change in transferrin concentration
Time frame: Baseline and after 12 months approximately
Change in ferritin concentration
Time frame: Baseline and after 12 months approximately
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- BackgroundMinisterio De Salud y Protección Social. Estrategia Nacional para la Prevención y Control de las Deficiencias de Micronutrientes en Colombia 2014 - 2021. Bogotá D.C., Colombia. 2015.
- BackgroundWorld Health Organization and Food and Agriculture Organization of the United Nations. Guidelines on Food Fortification with Micronutrients. Editado por Lindsay Allen y cols.
- Background: PubMed 12751414Black R. Micronutrient deficiency--an underlying cause of morbidity and mortality. Bull World Health Organ. 2003;81(2):79. Epub 2003 Mar 25. No abstract available.
- BackgroundMinisterio de la Protección Social. Instituto Colombiano de Bienestar Familiar. ENSIN 2010- Encuesta Nacional de Situación Nutricional en Colombia 2010. Ed. Bogotá: 2011.
- BackgroundOMS. Directriz: Uso de micronutrientes en polvo para la fortificación domiciliaria de los alimentos consumidos por lactantes y niños de 6 a 23 meses de edad. Ginebra, Organización Mundial de la Salud, 2012.
- Background: PubMed 15696200Zlotkin SH, Schauer C, Christofides A, Sharieff W, Tondeur MC, Hyder SM. Micronutrient sprinkles to control childhood anaemia. PLoS Med. 2005 Jan;2(1):e1. doi: 10.1371/journal.pmed.0020001.
- Background: PubMed 21901727De-Regil LM, Suchdev PS, Vist GE, Walleser S, Pena-Rosas JP. Home fortification of foods with multiple micronutrient powders for health and nutrition in children under two years of age. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008959. doi: 10.1002/14651858.CD008959.pub2.
- Background: PubMed 26778801Hotz C, Pelto G, Armar-Klemesu M, Ferguson EF, Chege P, Musinguzi E. Constraints and opportunities for implementing nutrition-specific, agricultural and market-based approaches to improve nutrient intake adequacy among infants and young children in two regions of rural Kenya. Matern Child Nutr. 2015 Dec;11 Suppl 3(Suppl 3):39-54. doi: 10.1111/mcn.12245.
- Background: PubMed 22705425Inayati DA, Scherbaum V, Purwestri RC, Wirawan NN, Suryantan J, Hartono S, Bloem MA, Pangaribuan RV, Biesalski HK, Hoffmann V, Bellows AC. Combined intensive nutrition education and micronutrient powder supplementation improved nutritional status of mildly wasted children on Nias Island, Indonesia. Asia Pac J Clin Nutr. 2012;21(3):361-73.
- Background: PubMed 25266222Attanasio OP, Fernandez C, Fitzsimons EO, Grantham-McGregor SM, Meghir C, Rubio-Codina M. Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial. BMJ. 2014 Sep 29;349:g5785. doi: 10.1136/bmj.g5785.
- Background: PubMed 29349132Andrew A, Attanasio O, Fitzsimons E, Rubio-Codina M. Why is multiple micronutrient powder ineffective at reducing anaemia among 12-24 month olds in Colombia? Evidence from a randomised controlled trial. SSM Popul Health. 2016 Mar 7;2:95-104. doi: 10.1016/j.ssmph.2016.02.004. eCollection 2016 Dec.
- Background: PubMed 22801933Jack SJ, Ou K, Chea M, Chhin L, Devenish R, Dunbar M, Eang C, Hou K, Ly S, Khin M, Prak S, Reach R, Talukder A, Tokmoh LO, Leon de la Barra S, Hill PC, Herbison P, Gibson RS. Effect of micronutrient sprinkles on reducing anemia: a cluster-randomized effectiveness trial. Arch Pediatr Adolesc Med. 2012 Sep;166(9):842-50. doi: 10.1001/archpediatrics.2012.1003.
- Sitio Web. Proyecto Seguridad Alimentaria Nutricional S.A.N. Nariño.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara E. Del Castillo Matamoros, Professor study director
Universidad Nacional de Colombia
Javier H. Eslava Schmalbach, Professor study director
Universidad Nacional de Colombia
Nathalie Ospina Lizarazo, Student principal investigator
Universidad Nacional de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoglobin and Anemia, run by Universidad Nacional de Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin concentration (time frame: Baseline and after 12 months approximately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03313089, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.