Impact of Low Dose Iron-containing Micronutrient Powders on Iron Status and Morbidity of Young Children in Ethiopia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02479815
• Date of registration: 16/06/2015
• Prospective Registration: No
• Primary sponsor: Ethiopian Public Health Institute
• Public title: Impact of Low Dose Iron-containing Micronutrient Powders on Iron Status and Morbidity of Young Children in Ethiopia
• Scientific title: Assessing the Safety of Iron Supplementation in Micronutrient Powder (MNPs)
• Date of first enrolment: March 2015
• Target sample size: 2356
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02479815
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Ethiopia

Contacts

• Name: Saskia JM Osendarp, PhD
• Affiliation: Micronutrient Initiative

• Name: Inge D Brouwer, PhD
• Affiliation: Wageningen University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Living in one of the selected intervention and non-intervention villages

- Between 6 months and 11.99 months old at the day of recruitment

- Have not yet been provided with MNPs as part of the project interventions

- Free of chronic conditions that may impact their health

- Caregivers do not plan to migrate out of the study area

- Caregivers have provided written informed consent for this additional safety component

Exclusion Criteria:

- Children who are severely malnourished (Wt/Ht Z-score < -3 SD) will be referred to
treatment and excluded from the safety component

- Children with a chronic disease and/or chronic use of medications

- Children who are severe anemic (Hb< 70 g/L)



Age minimum: 6 Months
Age maximum: 12 Months
Gender: All

Health Condition(s) or Problem(s) studied

Infant Morbidity

Nutritional Anemia

Intervention(s)

Dietary Supplement: Micronutrient Powder (MNP)

Primary Outcome(s)

Anemia [Time Frame: Baseline and Endline]

% of new acute diarrhea episodes (>3 loose stools/day) per 52 surveillance weeks [Time Frame: Up to one year]

Secondary Outcome(s)

Growth [Time Frame: Up to one year]

Prevalence of Fever [Time Frame: Up to one year]

% of new respiratory infection episodes (cough and/or difficult breathing with or without fever, accompanied by rapid breathing and chest in drawing) per 52 surveillance weeks [Time Frame: Up to one year]

Iron status [Time Frame: Baseline and Endline]

Secondary ID(s)

EPHI_FSNRD_CF_MNP001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Micronutrient Initiative

Wageningen University