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

January 29, 2018 updated by: Ethiopian Public Health Institute

Assessing the Safety of Iron Supplementation in Micronutrient Powder (MNPs)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For morbidity assessment 65 eligible children per cluster (18 intervention and 18non-intervention villages) a total of 2340 will be randomly selected The sample size was calculated based on an expected 12% increase in the incidence of overall diarrhoea and 30% decrease in anemia in the intervention group. The investigators assume that the investigators will be able to detect this increase with 80% power and 95% confidence interval, with an assumed 10% drop-out and design effect of two.

  • Morbidity from infectious diseases will be assessed by means of a standardized recall questionnaire. Data will be collected on the following symptoms: diarrhea, respiratory signs, fever and other illnesses. Children who require medical treatment will be examined by a Health Officer at the health center following standard protocols of the Federal Ministry of Health.
  • Biochemical iron status will be assessed from non-fasting venous morning blood samples. Blood samples will be kept cool and serum separated and frozen at -20oC within 3 hours of collection. Hemoglobin, serum ferritin, C-reactive protein (CRP), soluble transferrin receptor and AGP will be assessed following standardized methodologies at the laboratories of the Ethiopian Public Health Institute (EPHI).
  • Anthropometry: Trained field staff will collect duplicate measurements every four months of weight, recumbent length (infants) and height (children > 12 months) using standardized methods and high quality equipment. Z-scores for length-for-age (LAZ), weight-for-age (WAZ) and weight-for-length (WLZ) will be calculated, using the 2006 WHO Child Growth Standard; and stunting, under-weight and wasting will be defined as LAZ, WAZ and LAZ <-2 SD, respectively.
  • Infant feeding status. Information on infant feeding status will be collected every four months by means of a standardized questionnaire.
  • Compliance to the program intervention: will be assessed by counting the number of returned and used MNP sachets every 2 weeks.
  • Social, economic and demographic characteristics: will be collected in baseline questionnaires using Demographic and Health Survey methods.

Data will be analysed on an intention-to-treat basis, using the SPSS 19.0 statistical program. Random effect models will be used to account for repeated measures or episodes within children, and multiple children in each cluster.

For morbidity, the number of actual surveillance days will be counted by subtracting the days on which no recall data were available from the total days of follow-up. For the analysis of disease incidence, differences between groups will be assessed with random effects regression including number of episodes as dependent, control- or intervention as independent, and total days of actual surveillance as off-set term in the model. Longitudinal prevalence of disease will be calculated for each individual as the percentage of actual surveillance days with illness. All continuous variables (longitudinal prevalence, body iron status, mean and total weight and height gain) will be analysed using linear mixed models using cluster, household and child as random effects to account for clustered observations. Mixed effects logistic regression analysis will be used to evaluate binary outcomes (anemia, iron deficiency and iron-deficiency anemia), using cluster, household and child as random effects. All models will include the following fixed effects as co-variates: child's sex, socio-economic status, and baseline values. Non-normal distributed values will be log-transformed. P-values of < 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

2356

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Ababa, Ethiopia, 1242/5456
        • Ethiopian Public Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1gm MNP, 15 sachets per month
Quasi experimental matched control cluster design where for every child 1gm Micronutrient Powder (MNP) for two days, is given which totlas to 15 sachets per month
Dietary supplement: Micronutrient Powder (MNP)
Every month, 15 MNPs sachets will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification on every alternate day. The MNPs sachets will contain 6 mg Fe together with 14 other vitamins and minerals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anemia
Time Frame: Baseline and Endline
Hemoglobin <110g/L
Baseline and Endline
% of new acute diarrhea episodes (>3 loose stools/day) per 52 surveillance weeks
Time Frame: Up to one year
Morbidity from diarrhea (prevalence and incidence rate)
Up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron status
Time Frame: Baseline and Endline
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
% 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
Morbidity from any types of flu (flu,common cold or cough)-prevalence and incidence rate
Up to one year
Prevalence of Fever
Time Frame: Up to one year
Body temperature >37.5 degree Centigrade per 52 surveillance weeks
Up to one year
Growth
Time Frame: Up to one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethiopian Public Health Institute

Collaborators

Wageningen University
Micronutrient Initiative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (ESTIMATE)

June 24, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPHI_FSNRD_CF_MNP001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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