NCT03313089

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2017

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

October 9, 2017

Last Update Submit

October 10, 2018

Conditions

Keywords

micronutrient powdersspinklesnutritionfood security programnutritional programhemoglobinanemia

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin concentration

    g/dL

    Baseline and after 12 months approximately

Secondary Outcomes (4)

  • Vitamin A (change in serum retinol concentration)

    Baseline and after 12 months approximately

  • Change in zinc concentration

    Baseline and after 12 months approximately

  • Change in transferrin concentration

    Baseline and after 12 months approximately

  • Change in ferritin concentration

    Baseline and after 12 months approximately

Study Arms (2)

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.

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.

Interventions

Activities of the project "Papas más nutritivas"

PSAN + MNP

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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,

You may qualify if:

  • Boys and girls of 6 months to 5 years of age receiving home fortification with micronutrient powders.

You may not qualify if:

  • Children who are consuming nutritional complements or supplements.
  • Children undergoing treatment for anemia or other micronutrient deficiencies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Nacional de Colombia

Bogotá, Colombia

Location

Related Publications (16)

  • 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.

    BACKGROUND
  • World Health Organization and Food and Agriculture Organization of the United Nations. Guidelines on Food Fortification with Micronutrients. Editado por Lindsay Allen y cols.

    BACKGROUND
  • 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.

    PMID: 12751414BACKGROUND
  • Ministerio de la Protección Social. Instituto Colombiano de Bienestar Familiar. ENSIN 2010- Encuesta Nacional de Situación Nutricional en Colombia 2010. Ed. Bogotá: 2011.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 15696200BACKGROUND
  • De-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.

    PMID: 21901727BACKGROUND
  • Hotz 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.

    PMID: 26778801BACKGROUND
  • Inayati 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.

    PMID: 22705425BACKGROUND
  • Attanasio 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.

    PMID: 25266222BACKGROUND
  • Andrew 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.

    PMID: 29349132BACKGROUND
  • Jack 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.

    PMID: 22801933BACKGROUND
  • Aboud 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.

    PMID: 21502222BACKGROUND
  • Avula 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.

    PMID: 21346106BACKGROUND
  • Osei 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.

    PMID: 25682798BACKGROUND
  • Del Castillo SE, Mosquera T, Suárez EL, Heredia P. Nutritional Situation of Rural Communities in Nariño, Colombia 2013. Food and Nutrition Sciences (5): 1521-1528, 2014

    BACKGROUND

Related Links

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sara E. Del Castillo Matamoros, Professor

    Universidad Nacional de Colombia

    STUDY DIRECTOR
  • Javier H. Eslava Schmalbach, Professor

    Universidad Nacional de Colombia

    STUDY DIRECTOR
  • Nathalie Ospina Lizarazo, Student

    Universidad Nacional de Colombia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 18, 2017

Study Start

July 7, 2017

Primary Completion

November 26, 2017

Study Completion

November 26, 2017

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations