Nutritional AnemiaNCT02479815
Impact of Low Dose Iron-containing Micronutrient Powders on Iron Status and Morbidity of Young Children in Ethiopia
A study testing Micronutrient Powder (MNP) in people with Nutritional Anemia and Infant Morbidity, run by Ethiopian Public Health Institute at 1 site in Ethiopia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Anemia, Infant Morbidity
- What is being tested?
- Micronutrient Powder (MNP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,356 participants
- Where
- 1 siteEthiopia
- Study dates
- Mar 2015to Aug 2016
- Phase
- Interventional
- 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 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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?
- 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:
- Anthropometry (weight, height, MUAC) every 4 months
- Breastfeeding status and consumption of processed complementary food portions in the previous week -every 4 months
- Compliance to study intervention.
Read the 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.
- Conditions
- Nutritional Anemia, Infant Morbidity
- Being tested
- Micronutrient Powder (MNP)
- Keywords
- Complementary feeding recommendation, Program evaluation, Process and impact evaluation, Micronutrient powder (MNP) safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronutrient Powder (MNP)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| 1gm MNP, 15 sachets per month | Other | 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 Receives: Dietary Supplement: Micronutrient Powder (MNP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
Hemoglobin <110g/L
Measured: Baseline and Endline
% of new acute diarrhea episodes (>3 loose stools/day) per 52 surveillance weeks
Morbidity from diarrhea (prevalence and incidence rate)
Measured: Up to one year
Secondary outcomes (4)
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.
Measured: 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
Morbidity from any types of flu (flu,common cold or cough)-prevalence and incidence rate
Measured: Up to one year
Prevalence of Fever
Body temperature >37.5 degree Centigrade per 52 surveillance weeks
Measured: Up to one year
Growth
Change in height-for-age Z-score (HAZ), weight-for-length Z-score (WHZ), and weight-for-age Z-score (WAZ)
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nutritional AnemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethiopian Public Health Institute
- Sponsor type
- Other government
- Collaborators
- Micronutrient Initiative, Wageningen University
- Responsible party
- Sponsor
- Investigators
- Saskia JM Osendarp, PhD, Study chair, Micronutrient InitiativeInge D Brouwer, PhD, Study director, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479815
- Sponsor's protocol ID
- EPHI_FSNRD_CF_MNP001
- Status last verified
- Feb 2017
- First submitted
- 16 Jun 2015
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.
PubMed 10342698Zimmermann 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.
PubMed 20962160Erhardt 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. doi: 10.1093/jn/134.11.3127.
PubMed 15514286Cook JD, Flowers CH, Skikne BS. The quantitative assessment of body iron. Blood. 2003 May 1;101(9):3359-64. doi: 10.1182/blood-2002-10-3071. Epub 2003 Jan 9.
PubMed 12521995Samuel A, Osendarp SJM, Feskens EJM, Lelisa A, Adish A, Kebede A, Brouwer ID. Gender differences in nutritional status and determinants among infants (6-11 m): a cross-sectional study in two regions in Ethiopia. BMC Public Health. 2022 Feb 26;22(1):401. doi: 10.1186/s12889-022-12772-2.
PubMed 35219315
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety of Iron Supplementation in Micronutrient Powder (MNPs)
- ClinicalTrials.gov ID
- NCT02479815
- Acronym / sponsor ID
- EPHI_FSNRD_CF_MNP001
- Conditions
- Nutritional Anemia, Infant Morbidity
- Keywords
- Complementary feeding recommendation, Program evaluation, Process and impact evaluation, Micronutrient powder (MNP) safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,356 participants (actual)
- Lead sponsor
- Ethiopian Public Health InstituteOther government
- Collaborators
- Micronutrient Initiative, Wageningen University
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Jun 2015 (estimated)
- 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 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:
- 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?
- 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:
- Anthropometry (weight, height, MUAC) every 4 months
- Breastfeeding status and consumption of processed complementary food portions in the previous week -every 4 months
- Compliance to study intervention.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1gm MNP, 15 sachets per month | Other | Dietary Supplement: Micronutrient Powder (MNP)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 |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| 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. | Dietary supplement | 1gm MNP, 15 sachets per month |
Primary outcome
Anemia
Time frame: Baseline and Endline
Hemoglobin <110g/L
% 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)
4 secondary outcomes
Iron status
Time frame: 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
Prevalence of Fever
Time frame: Up to one year
Growth
Time frame: Up to one year
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 31 Jan 2018.
- Background: PubMed 10342698Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.
- Background: PubMed 20962160Zimmermann 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.
- Background: PubMed 15514286Erhardt 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. doi: 10.1093/jn/134.11.3127.
- Background: PubMed 12521995Cook JD, Flowers CH, Skikne BS. The quantitative assessment of body iron. Blood. 2003 May 1;101(9):3359-64. doi: 10.1182/blood-2002-10-3071. Epub 2003 Jan 9.
- Derived from this study: PubMed 35219315Samuel A, Osendarp SJM, Feskens EJM, Lelisa A, Adish A, Kebede A, Brouwer ID. Gender differences in nutritional status and determinants among infants (6-11 m): a cross-sectional study in two regions in Ethiopia. BMC Public Health. 2022 Feb 26;22(1):401. doi: 10.1186/s12889-022-12772-2.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Saskia JM Osendarp, PhD study chair
Micronutrient Initiative
Inge D Brouwer, PhD study director
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronutrient Powder (MNP) in people with Nutritional Anemia and Infant Morbidity, run by Ethiopian Public Health Institute at 1 site in Ethiopia.
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 6 inclusion and 3 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 31 Jan 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 Ethiopia. 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?
Anemia (time frame: Baseline and Endline). The study lists 2 primary outcomes in all. 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 NCT02479815, which also lists 5 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 31 Jan 2018.