AnemiaNCT02610881
Acceptability and Feasibility of Micronutrient Powders Versus Iron Syrup for Anemia Prevention in Young Children
A study testing Iron and Folic Acid (IFA), Micronutrient Powders (MNP) and Iron Plus Strategy Counseling in people with Anemia, run by Emory University at 1 site in India.
Trial summary
This study seeks to assess the acceptability, compliance, and preference for iron supplementation; micronutrient powders (MNP) versus iron syrup. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy… Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Anemia
- What is being tested?
- Iron and Folic Acid (IFA), Micronutrient Powders (MNP) and Iron Plus Strategy Counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2015to Apr 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 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Singleton Children or one child per home
Who cannot join
- Currently taking iron supplements
- Mid upper arm circumference (MUAC) or less than 11.5 cm
- Suspected severe anemia
- Known case of haemoglobinopathy
- History of repeated blood transfusion
- Current pneumonia
- Current fever
- Acute diarrhea
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to assess the acceptability, compliance, and preference for iron supplementation; micronutrient powders (MNP) versus iron syrup. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy preference.
Read the detailed description
The specific aims of this study are to assess the acceptability of, compliance, and preference for two delivery vehicles for pediatric prophylaxis iron supplementation (micronutrient powders (MNP) that contain iron versus iron syrup) among rural households in Bihar India delivered through home visits by front line health workers. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy preference.
- Conditions
- Anemia
- Being tested
- Iron and Folic Acid (IFA), Micronutrient Powders (MNP), Iron Plus Strategy Counseling
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron and Folic Acid (IFA)Dietary supplement
1 mg of IFA syrup (containing 20 mg of elemental iron and 100 mcg of folic acid) will be taken twice per week for one month.
Micronutrient Powders (MNP)Dietary supplement
One sachet of micronutrient powder will be mixed into food to be taken once daily for a total of one month. One sachet of micronutrient powders includes the following:
Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin Base
Iron Plus Strategy CounselingBehavioural
Mothers of participants will receive counseling on the benefits of regular iron intake, side effects associated with IFA administration, and the preservation of the IFA bottle and MNP sachets.
| Study group | Role | What they receive |
|---|---|---|
| Iron and Folic Acid (IFA)/Micronutrient Powders (MNP) | Experimental | Participants will receive iron and folic acid (IFA) drops for one month followed by a two week washout period. Participants will then receive micronutrient powders (MNP) for one month. Mothers of participants will receive counseling on the benefits of iron intake, side effects of IFA, and preservation of IFA bottles and MNP sachets. Receives: Dietary Supplement: Iron and Folic Acid (IFA); Dietary Supplement: Micronutrient Powders (MNP); Behavioral: Iron Plus Strategy Counseling |
| Micronutrient Powders (MNP)/Iron and Folic Acid (IFA) | Experimental | Participants will receive micronutrient powders (MNP) for one month followed by a two week washout period. Participants will then receive iron and folic acid (IFA) drops for one month. Mothers of participants will receive counseling on the benefits of iron intake, side effects of IFA, and preservation of IFA bottles and MNP sachets. Receives: Dietary Supplement: Iron and Folic Acid (IFA); Dietary Supplement: Micronutrient Powders (MNP); Behavioral: Iron Plus Strategy Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of iron and folic acid (IFA) syrup
Caregiver change in acceptability of iron and folic acid (IFA) syrup will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
Measured: Endline (Up to 5 months)
Acceptability of micronutrient powders (MNP)
Caregiver change in acceptability of micronutrient powders (MNP) will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
Measured: Endline (Up to 5 months)
Preference for vitamin supplementation
Caregiver change in preference for vitamin supplementation (IFA versus MNP) will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitu
Measured: Endline (Up to 5 months)
Vitamin supplementation compliance
Caregiver change in vitamin supplementation compliance will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
Measured: Baseline, Endline (Up to 5 months)
Secondary outcomes (2)
Change in perceived barriers to vitamin supplementation
Caregiver change in perceived barriers to vitamin supplementation will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
Measured: Baseline, Endline (Up to 5 months)
Preferred method of distribution
The preferred method of distribution will be discussed with front line workers in focus group discussions.
Measured: Endline (Up to 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- International Food Policy Research Institute
- Responsible party
- Principal investigator, Melissa Fox Young, Emory University
- Investigators
- Melissa Young, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610881
- Sponsor's protocol ID
- IRB00081930
- Status last verified
- Apr 2016
- First submitted
- 18 Nov 2015
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Young MF, Girard AW, Mehta R, Srikantiah S, Gosdin L, Menon P, Ramakrishnan U, Martorell R, Avula R. Acceptability of multiple micronutrient powders and iron syrup in Bihar, India. Matern Child Nutr. 2018 Apr;14(2):e12572. doi: 10.1111/mcn.12572. Epub 2017 Dec 6.
PubMed 29210507
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Micronutrient Powders Versus Iron Syrup for Anemia Prevention in Young Children
- ClinicalTrials.gov ID
- NCT02610881
- Acronym / sponsor ID
- IRB00081930
- Conditions
- Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- International Food Policy Research Institute
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Nov 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.
This study seeks to assess the acceptability, compliance, and preference for iron supplementation; micronutrient powders (MNP) versus iron syrup. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy preference.
Detailed description
The specific aims of this study are to assess the acceptability of, compliance, and preference for two delivery vehicles for pediatric prophylaxis iron supplementation (micronutrient powders (MNP) that contain iron versus iron syrup) among rural households in Bihar India delivered through home visits by front line health workers. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy preference.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron and Folic Acid (IFA)/Micronutrient Powders (MNP) | Experimental | Dietary Supplement: Iron and Folic Acid (IFA), Dietary Supplement: Micronutrient Powders (MNP), Behavioral: Iron Plus Strategy CounselingParticipants will receive iron and folic acid (IFA) drops for one month followed by a two week washout period. Participants will then receive micronutrient powders (MNP) for one month. Mothers of participants will receive counseling on the benefits of iron intake, side effects of IFA, and preservation of IFA bottles and MNP sachets. |
| Micronutrient Powders (MNP)/Iron and Folic Acid (IFA) | Experimental | Dietary Supplement: Iron and Folic Acid (IFA), Dietary Supplement: Micronutrient Powders (MNP), Behavioral: Iron Plus Strategy CounselingParticipants will receive micronutrient powders (MNP) for one month followed by a two week washout period. Participants will then receive iron and folic acid (IFA) drops for one month. Mothers of participants will receive counseling on the benefits of iron intake, side effects of IFA, and preservation of IFA bottles and MNP sachets. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Singleton Children or one child per home
Key exclusion criteria (8 listed)
- Currently taking iron supplements
- Mid upper arm circumference (MUAC) or less than 11.5 cm
- Suspected severe anemia
- Known case of haemoglobinopathy
- History of repeated blood transfusion
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 |
|---|---|---|
| Iron and Folic Acid (IFA)1 mg of IFA syrup (containing 20 mg of elemental iron and 100 mcg of folic acid) will be taken twice per week for one month. | Dietary supplement | Iron and Folic Acid (IFA)/Micronutrient Powders (MNP), Micronutrient Powders (MNP)/Iron and Folic Acid (IFA) |
| Micronutrient Powders (MNP)One sachet of micronutrient powder will be mixed into food to be taken once daily for a total of one month. One sachet of micronutrient powders includes the following: Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin Base | Dietary supplement | Iron and Folic Acid (IFA)/Micronutrient Powders (MNP), Micronutrient Powders (MNP)/Iron and Folic Acid (IFA) |
| Iron Plus Strategy CounselingMothers of participants will receive counseling on the benefits of regular iron intake, side effects associated with IFA administration, and the preservation of the IFA bottle and MNP sachets. | Behavioural | Iron and Folic Acid (IFA)/Micronutrient Powders (MNP), Micronutrient Powders (MNP)/Iron and Folic Acid (IFA) |
Primary outcome
Acceptability of iron and folic acid (IFA) syrup
Time frame: Endline (Up to 5 months)
Caregiver change in acceptability of iron and folic acid (IFA) syrup will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
Acceptability of micronutrient powders (MNP)
Time frame: Endline (Up to 5 months)
Caregiver change in acceptability of micronutrient powders (MNP) will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
Preference for vitamin supplementation
Time frame: Endline (Up to 5 months)
Caregiver change in preference for vitamin supplementation (IFA versus MNP) will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitu
Vitamin supplementation compliance
Time frame: Baseline, Endline (Up to 5 months)
Caregiver change in vitamin supplementation compliance will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
2 secondary outcomes
Change in perceived barriers to vitamin supplementation
Time frame: Baseline, Endline (Up to 5 months)
Preferred method of distribution
Time frame: Endline (Up to 5 months)
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 25 Apr 2016.
- Derived from this study: PubMed 29210507Young MF, Girard AW, Mehta R, Srikantiah S, Gosdin L, Menon P, Ramakrishnan U, Martorell R, Avula R. Acceptability of multiple micronutrient powders and iron syrup in Bihar, India. Matern Child Nutr. 2018 Apr;14(2):e12572. doi: 10.1111/mcn.12572. Epub 2017 Dec 6.
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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.
Melissa Young, PhD principal investigator
Emory 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 Iron and Folic Acid (IFA), Micronutrient Powders (MNP) and Iron Plus Strategy Counseling in people with Anemia, run by Emory University at 1 site in India.
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 1 inclusion and 8 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 25 Apr 2016. 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 India. 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?
Acceptability of iron and folic acid (IFA) syrup (time frame: Endline (Up to 5 months)). The study lists 4 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 NCT02610881, which also lists 1 linked publication.
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 25 Apr 2016.