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Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana

Primary Purpose

Iron Deficiency (ID), General Anemia, Iron Deficiency Anemia (IDA)

Status
Completed
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Intervention Group
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency (ID)

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

Not meeting the inclusion criteria

Sites / Locations

  • Builsa North and Kessena Nankana West Districts

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Iron Deficiency (ID)
ID measured using serum transferrin receptor (Stfr). Cut off for ID (women - stfr>4.40ug/l, children - stfr>2.85ug/l).
General Anemia
General anemia measured using hemoglobin levels (Hb). Cut off for General anemia (women - Hb<12g/dl, children - Hb<11g/dl)
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).
Iodine status of participants
Iodine status will be measured by urinary iodine concentration (ug/l)
Hibiscus Sabdariffa produced/harvested from container gardening
Quantity of Hibiscus Sabdariffa leaves (kg) per container
Income generated form container gardening
Income (cedis) generated from cabbage produced per container

Secondary Outcome Measures

Full Information

First Posted
November 14, 2018
Last Updated
November 23, 2018
Sponsor
Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT03754998
Brief Title
Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana
Official Title
Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
September 8, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency (ID), General Anemia, Iron Deficiency Anemia (IDA)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Quasi experimental
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Iron Deficiency (ID)
Description
ID measured using serum transferrin receptor (Stfr). Cut off for ID (women - stfr>4.40ug/l, children - stfr>2.85ug/l).
Time Frame
12 weeks
Title
General Anemia
Description
General anemia measured using hemoglobin levels (Hb). Cut off for General anemia (women - Hb<12g/dl, children - Hb<11g/dl)
Time Frame
12 weeks
Title
Iron Deficiency Anemia (IDA)
Description
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).
Time Frame
12 weeks
Title
Iodine status of participants
Description
Iodine status will be measured by urinary iodine concentration (ug/l)
Time Frame
12 weeks
Title
Hibiscus Sabdariffa produced/harvested from container gardening
Description
Quantity of Hibiscus Sabdariffa leaves (kg) per container
Time Frame
15 weeks
Title
Income generated form container gardening
Description
Income (cedis) generated from cabbage produced per container
Time Frame
15 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Not meeting the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clement Professor Won Song
Organizational Affiliation
Michigan State University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Clement Kubuga
Organizational Affiliation
University for Development Studies - Ghana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Builsa North and Kessena Nankana West Districts
City
Bolgatanga
State/Province
Upper East Region
ZIP/Postal Code
00233
Country
Ghana

12. IPD Sharing Statement

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Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana

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