Infant Morbidity Clinical Trial
Official title:
Assessing the Safety of Iron Supplementation in Micronutrient Powder (MNPs)
Verified date | February 2017 |
Source | Ethiopian Public Health Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to assess the safety of iron supplementation in MNPs. A
quasi-experimental matched-control cluster design will be used in, purposely selected, 18
intervention and 18 matched-control clusters of Oromia and South Nations Nationalities and
People (SNNP) regions of Ethiopia. A total of 2340 infants 6-11 months of age, from
intervention and non-intervention clusters will be enrolled and followed longitudinally for
12 months. Morbidity data using standardized questionnaire, will be collected at baseline,
and every two weeks for a period of 12 months
Research questions to be answered in this study are:
1. Is the provision of low dose iron-containing Micronutrient Powders (MNPs) to young
children with or without iron deficiency safe, as assessed by their morbidity from
infectious diseases?
2. What is the impact of the provision of low dose iron-containing Micronutrient Powders
(MNPs) to young children on (body) iron status? Morbidity data will be collected at
baseline, and every two weeks in the same cohort of children.
Body iron status will be assessed at baseline and endline as measured by serum ferritin,
serum transferrin receptor, hemoglobin concentration, CRP and AGP.
In addition data on the following outcomes will be collected in these children:
1. Anthropometry (weight, height, MUAC) every 4 months
2. Breastfeeding status and consumption of processed complementary food portions in the
previous week -every 4 months
3. Compliance to study intervention.
Status | Completed |
Enrollment | 2356 |
Est. completion date | August 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 12 Months |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Ethiopian Public Health Institute | Addis Ababa |
Lead Sponsor | Collaborator |
---|---|
Ethiopian Public Health Institute | Micronutrient Initiative, Wageningen University |
Ethiopia,
Cook JD, Flowers CH, Skikne BS. The quantitative assessment of body iron. Blood. 2003 May 1;101(9):3359-64. Epub 2003 Jan 9. — View Citation
Erhardt JG, Estes JE, Pfeiffer CM, Biesalski HK, Craft NE. Combined measurement of ferritin, soluble transferrin receptor, retinol binding protein, and C-reactive protein by an inexpensive, sensitive, and simple sandwich enzyme-linked immunosorbent assay technique. J Nutr. 2004 Nov;134(11):3127-32. — View Citation
Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. Review. — View Citation
Zimmermann MB, Chassard C, Rohner F, N'goran EK, Nindjin C, Dostal A, Utzinger J, Ghattas H, Lacroix C, Hurrell RF. The effects of iron fortification on the gut microbiota in African children: a randomized controlled trial in Cote d'Ivoire. Am J Clin Nutr. 2010 Dec;92(6):1406-15. doi: 10.3945/ajcn.110.004564. Epub 2010 Oct 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anemia | Hemoglobin <110g/L | Baseline and Endline | |
Primary | % of new acute diarrhea episodes (>3 loose stools/day) per 52 surveillance weeks | Morbidity from diarrhea (prevalence and incidence rate) | Up to one year | |
Secondary | Iron status | Iron status measured by iron deficiency (ID) and iron deficiency anemia (IDA). ID defined as serum ferritin (SF) concentration <12µg/L. IDA defined as hemoglobin <110g/L with SF<12µg/L. | Baseline and Endline | |
Secondary | % 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 | Morbidity from any types of flu (flu,common cold or cough)-prevalence and incidence rate | Up to one year | |
Secondary | Prevalence of Fever | Body temperature >37.5 degree Centigrade per 52 surveillance weeks | Up to one year | |
Secondary | Growth | Change in height-for-age Z-score (HAZ), weight-for-length Z-score (WHZ), and weight-for-age Z-score (WAZ) | Up to one year |
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