Iron Deficiency (ID)NCT03754998
Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana
A study testing Intervention Group in people with Iron Deficiency (ID) and General Anemia, run by Michigan State University at 1 site in Ghana.
Trial summary
BACKGROUND Ghana has reduced food insecurity prevalence by 49.2% in two decades. However, prevalence of malnutrition especially stunting (in <children5yr) has not matched the changes in food security levels. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (ID), General Anemia, Iron Deficiency Anemia (IDA)
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteGhana
- Study dates
- 20 May 2017to 29 Sep 2017
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be a woman (15-49 y) and having a child (6 - 23 months)
- Live in research settings for the entire research duration (May 2016 - September 2017)
- Live in selected communities in the Kassena Nankana West and Builsa North Districts of the Upper East Region of Ghana
- Selected districts should be among the top five food insecure districts
- Households in selected communities should have access to water throughout the dry season without shortages
- Selected communities should have sizeable number of children (6 - 23 months old) for a good sampling frame
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Ghana1 site
Builsa North and Kessena Nankana West Districts
Bolgatanga, Upper East Region, 00233
About this study
BACKGROUND Ghana has reduced food insecurity prevalence by 49.2% in two decades. However, prevalence of malnutrition especially stunting (in <children5yr) has not matched the changes in food security levels. Of several key nutritional factors that lead to stunting, nutritional status of such trace minerals as iodine, iron and zinc has not been studied. Nutritional inadequacy of these trace minerals may be detected by estimation of dietary intake, and time-consuming and costly biochemical measurements of respective biomarkers. Since there is no means to estimate dietary intake of the trace minerals in Ghana, due to incomplete food composition data of the nutrients, identifying validated non-invasive, dietary approaches to predict the biomarker status of these trace minerals are critical in counteracting the challenges surrounding the persistent stunting due to micronutrient deficiencies in Ghana. Additionally, exploring alternative approaches to providing access to foods rich in trace minerals at household level is crucial.
STUDY AIMS AND HYPOTHESIS The ultimate goal of this research is to increase knowledge base on improving trace mineral status in mother-child (6-23 mo) dyads through a sustainable community-based interventions in northern Ghana. Investigators will begin with iron and iodine that impair mothers and young children's growth and cognitive development most with three aims: 1) to develop dietary screening tools that are validated by biomarkers for early detection of deficiencies, 2) to determine efficacy (dose responses) of feeding indigenous nutrient-rich meals in preventing deficiencies and improving iron and iodine status, and 3) to demonstrate sustainable and scalable improvement of food systems through a container gardening project for iron-rich Hibiscus sabdarifa for consumption and income by empowering women during the dry/lean season in northern Ghana.
Read more
- Aims 1: To develop dietary screening tools that are validated by biomarkers for early detection of deficiencies among children 6-23 months and their mothers H1.1: Dietary diversity score can predict iron deficiency among children 6-23 months and their mothers.
H1.2: Dietary diversity score can predict iodine status deficiency among children 6-23 months and their mothers.
- Aims 2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron and iodine status of dyads H2.1: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron status of dyads H2.2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iodine status of dyads
- Aims 3: to demonstrate that container gardening can provide sustainable and scalable improvement of food systems for iron-rich Hibiscus sabdarifa for consumption and income during the dry/lean season in northern Ghana H3.1: Container gardening can provide adequate amounts of vegetables for mother and child dyad during the dry season H3.2: Container gardening can provide adequate income to purchase iodized salt and Amani for mother and child dyad during the dry season
SIGNIFICANCE This project addresses the gap in our knowledge and practices pertaining to serious and persisting trace mineral deficiencies that result in stunting and cognitive impairment in northern Ghana. Early detection of iron and iodine deficiencies with validated non-invasive dietary screening tools (aim 1), effective indigenous nutrient-rich meal-based programs (aim 2) and sustainable/scalable and women-led community-based food-system changing agricultural project (aim 3) are expected to be the most creative approach to counteract iron and iodine deficiencies in northern Ghana. This project will utilize science and education to change practices, environments and policies to reduce the prevalence of trace mineral deficiencies at the local, regional, national and global levels.
- Being tested
- Intervention Group
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
The participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities. Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron Deficiency (ID)
ID measured using serum transferrin receptor (Stfr). Cut off for ID (women - stfr>4.40ug/l, children - stfr>2.85ug/l).
Measured: 12 weeks
General Anemia
General anemia measured using hemoglobin levels (Hb). Cut off for General anemia (women - Hb<12g/dl, children - Hb<11g/dl)
Measured: 12 weeks
Iron Deficiency Anemia (IDA)
IDA is measured by concurrent presence of general anemia (women - Hb<12g/dl, children - Hb<11g/dl) and ID (women-stfr>4.40ug/l, children - stfr>2.85ug/l).
Measured: 12 weeks
Iodine status of participants
Iodine status will be measured by urinary iodine concentration (ug/l)
Measured: 12 weeks
Hibiscus Sabdariffa produced/harvested from container gardening
Quantity of Hibiscus Sabdariffa leaves (kg) per container
Measured: 15 weeks
Income generated form container gardening
Income (cedis) generated from cabbage produced per container
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start20 May 2017
- Primary completion8 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency (ID)Studies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Quasi experimental
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won O. Song, Michigan State University
- Investigators
- Clement Professor Won Song, Study chair, Michigan State UniversityClement Kubuga, Principal investigator, University for Development Studies - Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754998
- Sponsor's protocol ID
- WSong
- Status last verified
- Nov 2018
- First submitted
- 14 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana
- ClinicalTrials.gov ID
- NCT03754998
- Acronym / sponsor ID
- WSong
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 27 Nov 2018 (actual)
- 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.
BACKGROUND Ghana has reduced food insecurity prevalence by 49.2% in two decades. However, prevalence of malnutrition especially stunting (in <children5yr) has not matched the changes in food security levels. Of several key nutritional factors that lead to stunting, nutritional status of such trace minerals as iodine, iron and zinc has not been studied. Nutritional inadequacy of these trace minerals may be detected by estimation of dietary intake, and time-consuming and costly biochemical measurements of respective biomarkers. Since there is no means to estimate dietary intake of the trace minerals in Ghana, due to incomplete food composition data of the nutrients, identifying validated non-invasive, dietary approaches to predict the biomarker status of these trace minerals are critical in counteracting the challenges surrounding the persistent stunting due to micronutrient deficiencies in Ghana. Additionally, exploring alternative approaches to providing access to foods rich in trace minerals at household level is crucial.
STUDY AIMS AND HYPOTHESIS The ultimate goal of this research is to increase knowledge base on improving trace mineral status in mother-child (6-23 mo) dyads through a sustainable community-based interventions in northern Ghana. Investigators will begin with iron and iodine that impair mothers and young children's growth and cognitive development most with three aims: 1) to develop dietary screening tools that are validated by biomarkers for early detection of deficiencies, 2) to determine efficacy (dose responses) of feeding indigenous nutrient-rich meals in preventing deficiencies and improving iron and iodine status, and 3) to demonstrate sustainable and scalable improvement of food systems through a container gardening project for iron-rich Hibiscus sabdarifa for consumption and income by empowering women during the dry/lean season in northern Ghana.
- Aims 1: To develop dietary screening tools that are validated by biomarkers for early detection of deficiencies among children 6-23 months and their mothers H1.1: Dietary diversity score can predict iron deficiency among children 6-23 months and their mothers.
H1.2: Dietary diversity score can predict iodine status deficiency among children 6-23 months and their mothers.
- Aims 2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron and iodine status of dyads H2.1: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron status of dyads H2.2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iodine status of dyads
- Aims 3: to demonstrate that container gardening can provide sustainable and scalable improvement of food systems for iron-rich Hibiscus sabdarifa for consumption and income during the dry/lean season in northern Ghana H3.1: Container gardening can provide adequate amounts of vegetables for mother and child dyad during the dry season H3.2: Container gardening can provide adequate income to purchase iodized salt and Amani for mother and child dyad during the dry season
SIGNIFICANCE This project addresses the gap in our knowledge and practices pertaining to serious and persisting trace mineral deficiencies that result in stunting and cognitive impairment in northern Ghana. Early detection of iron and iodine deficiencies with validated non-invasive dietary screening tools (aim 1), effective indigenous nutrient-rich meal-based programs (aim 2) and sustainable/scalable and women-led community-based food-system changing agricultural project (aim 3) are expected to be the most creative approach to counteract iron and iodine deficiencies in northern Ghana. This project will utilize science and education to change practices, environments and policies to reduce the prevalence of trace mineral deficiencies at the local, regional, national and global levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi experimental
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention GroupThe participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Be a woman (15-49 y) and having a child (6 - 23 months)
- Live in research settings for the entire research duration (May 2016 - September 2017)
- Live in selected communities in the Kassena Nankana West and Builsa North Districts of the Upper East Region of Ghana
- Selected districts should be among the top five food insecure districts
- Households in selected communities should have access to water throughout the dry season without shortages
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
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 |
|---|---|---|
| Intervention GroupThe participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities. | Behavioural | Intervention Group |
Primary outcome
Iron Deficiency (ID)
Time frame: 12 weeks
ID measured using serum transferrin receptor (Stfr). Cut off for ID (women - stfr>4.40ug/l, children - stfr>2.85ug/l).
General Anemia
Time frame: 12 weeks
General anemia measured using hemoglobin levels (Hb). Cut off for General anemia (women - Hb<12g/dl, children - Hb<11g/dl)
Iron Deficiency Anemia (IDA)
Time frame: 12 weeks
IDA is measured by concurrent presence of general anemia (women - Hb<12g/dl, children - Hb<11g/dl) and ID (women-stfr>4.40ug/l, children - stfr>2.85ug/l).
Iodine status of participants
Time frame: 12 weeks
Iodine status will be measured by urinary iodine concentration (ug/l)
Hibiscus Sabdariffa produced/harvested from container gardening
Time frame: 15 weeks
Quantity of Hibiscus Sabdariffa leaves (kg) per container
Income generated form container gardening
Time frame: 15 weeks
Income (cedis) generated from cabbage produced per container
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 27 Nov 2018.
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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.
Clement Professor Won Song study chair
Michigan State University
Clement Kubuga principal investigator
University for Development Studies - Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Iron Deficiency (ID) and General Anemia, run by Michigan State University at 1 site in Ghana.
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 1 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 27 Nov 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 Ghana. 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?
Iron Deficiency (ID) (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2018.