AzTrials
AzTrials

Nutritional StatusAQUAFOODNCT07541742

Health and Nutritional Outcomes Among Young Females and Children in Southwest Bangladesh

An observational study of Nutritional Status and Micronutrient Status, run by University of Copenhagen at 1 site in Bangladesh.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to examine how societal and climate changes influence the nutritional status and fish consumption of young women over a 10 year period in southern Bangladesh, and how these factors affect their children's health. Read more about this study

Who is it for?
Ages 5 months to 27 yearsHealthy volunteers can take part
What is being tested?
The follow-up aims to evaluate natural changes occurring from adolescence to young adulthood with respect to the study objectives due to lifestyle and environmental factors, without any intervention.
How many people
240 participants
Where
1 siteBangladesh
Study dates
15 Apr 2026to 10 Dec 2026
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 5 months to 27 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: The study population is 240 young women who were studied as adolescents in 2017, now young women aged 22-26 years. If they have child aged 6 months to 5 years, the youngest child is included.

Who may be able to join

  • Young women aged 22-27 years who previously participated in the 2017 study. See study description.
  • If the women has a child age between 6 months to 5 years, the child child is included to be assessed

Who cannot join

  • Participants with serious health conditions that may interfere with study procedures or data collection.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nanna Roos, PhD contact

+45 3532 0829

nexs@nexs.ku.dk

Bangladesh1 site

  • International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b)

    Dhaka, Capital Region, 1000

    Gulshan Ara, MSc, +8802982700110, gulshan.ara@icddrb.org

Other trials in Bangladesh

About this study

Official title: Health and Nutritional Outcomes Among Young Females and Children in Southwest Bangladesh: A Cohort Study

This study aims to examine how societal and climate changes influence the nutritional status and fish consumption of young women over a 10 year period in southern Bangladesh, and how these factors affect their children's health. A cohort of 240 adolescents first studied in 2017 will be followed to assess changes in their dietary patterns, nutritional status, climate perceptions and mitigation practices, as well as the nutritional status of their children aged 6 months to 5 years.

The study in 2017 sampled 60 adolescent girls in each of four rural communities, plus a semi-rural community around a fish processing plant, representing in total 5 communities. Of these 60 X 5 = 300 girls, the current study follows up the individuals in the rural communities representing a cohort of 240.

Bangladesh faces high rates of adolescent malnutrition, with many girls married before 18 and suffering from chronic nutrient deficiencies. These issues have long-term impacts on health, productivity, and intergenerational well-being. By linking the fisheries and aquaculture sector, a key to Bangladesh's economy with public health and nutrition, this research aims to guide targeted policies for vulnerable coastal communities.

Read the detailed description

Aquatic foods are fundamental to the Bangladeshi diet, providing nearly two-thirds of total animal protein. Despite this, malnutrition remains a severe public health crisis with a complex etiology. Bangladesh faces a double burden of malnutrition, marked by persistently high rates of micronutrient deficiencies affecting roughly half of both pregnant and non-pregnant women alongside rising levels of overweight and obesity. These challenges are further exacerbated by substantial intrahousehold inequities in this patriarchal society. Disempowerment and early marriage disproportionately expose adolescent girls and young women to inadequate nutrient intake and poor health outcomes, perpetuating an intergenerational cycle of malnutrition. Furthermore, chronic undernutrition and stunting continue to affect a large proportion of children under five.

The problem is particularly acute in coastal communities, where climate change impacts such as salinity intrusion and extreme weather compromise food production and dietary diversity. Understanding and improving the dietary and nutritional status of adolescent girls and young women is therefore essential to breaking the cycle of poor health and ensuring long-term population well-being. Building on a 2017 study conducted with a cohort of 240 adolescents, this research aims to provide longitudinal insights into how nutritional status, female autonomy, aquatic food consumption, and dietary practices have influenced the health and well-being of these women and their children nearly after 10 years.

Hypotheses

  1. Nutritional status, fish consumption, and female autonomy during adolescence (2017) influence the nutritional status of young women in 2026 and that of their offspring.
  2. Fish consumption is positively associated with biological markers (omega-3 fatty acids, vitamin D levels, and stable isotope ratios in hair).

Objectives

  1. To assess changes in nutritional status, fish intake, socioeconomic factors, and female autonomy among young women from 2017 to 2026, and examine their associations with the nutritional status of their children (6 months-5 years).
  2. To investigate associations between assessed fish consumption and biological markers (omega-3, vitamin D, and stable isotope ratios in hair).

The study will be conducted in four distinct saline gradient agro-ecological zones across the shrimp-prawn farming regions of southwest Bangladesh, specifically in Fakirhat (Bagerhat District), Dumuria and Paikgacha (Khulna District), and Shyamnagor (Satkhira District).

Being tested
The follow-up aims to evaluate natural changes occurring from adolescence to young adulthood with respect to the study objectives due to lifestyle and environmental factors, without any intervention.
Keywords
Aquatic foods, adolescent nutrition, fish intake assessment, dietary biomarkers, climate adaptation, intergenerational nutrition, Bangladesh

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The follow-up aims to evaluate natural changes occurring from adolescence to young adulthood with respect to the study objectives due to lifestyle and environmental factors, without any intervention.Other

    There is no intervention

Study groups in NCT07541742
Study groupRoleWhat they receive
Follow-up of adolescent girls from 2017 to 2026The cohort of adolescent girls enrolled in 2017 at ages 12-16 will be followed up in 2026 to assess changes in their socioeconomic status, nutritional status, dietary intake, and women empowerment, and to examine how these factors are associated with the nutritional status of their children aged 6 months-5 years.
Receives: Other: The follow-up aims to evaluate natural changes occurring from adolescence to young adulthood with respect to the study objectives due to lifestyle and environmental factors, without any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Omega-3 status

    Eicosapentaenoic acid (EPA) in whole blood (% of total fatty acid)

    Measured: One sampling point between April and August 2026

  2. Omega-3 status

    Docosahexaenoic acid (DHA) in whole blood (% of total fatty acid)

    Measured: One sampling point between April and August 2026

  3. Micronutrient status

    Vitamin D (total 25-hydroxyvitamin D) concentration in blood, nmol/L

    Measured: One sampling point between April and August 2026

  4. Micronutrient status

    Hemoglobin concentration in blood (g/dL)

    Measured: One sampling point between April and August 2026

  5. Micronutrient status

    Ferritin concentration in blood (µg/L)

    Measured: One sampling point between April and August 2026

  6. Inflammation status

    C-reactive protein concentration in blood (mg/L)

    Measured: One sampling point between April and August 2026

  7. Inflammation status

    Alpha-1-acid glycoprotein concentration in blood (g/L)

    Measured: One sampling point between April and August 2026

Secondary outcomes (6)

  1. Nutritional status

    Height (cm)

    Measured: One measurement between April and August 2026

  2. Nutritional status

    Weight (kg)

    Measured: One measurement between April and August 2026

  3. Nutritional status

    Mid-upper arm circumference (cm)

    Measured: One measurement between April and August 2026

  4. Nutritional status

    Body mass index (kg/m^2)

    Measured: Between April and August 2026

  5. Hair stable isotopes ratio

    Isotope ratios of δ13C and δ15N in hair sample

    Measured: Between April 2026 to August 2026

  6. Fish consumption

    7 days recall, questionnaire

    Measured: Between April and August 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2026
  2. Study start15 Apr 2026 (estimated)
  3. Primary completion5 Aug 2026 (estimated)
  4. Study completion10 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
240 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07541742
Sponsor's protocol ID
PR-25044
Acronym
AQUAFOOD
Status last verified
Aug 2025
First submitted
27 Mar 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: According to the ethical approval, individual participant data cannot be shared with external parties and may only be obtained from the study coordinators upon reasonable request.

Publications

  • Ara G, Little DC, Mamun AA, de Roos B, Grieve E, Khanam M, Hasan SMT, Ireen S, Ali SD, Boitchi AB, Dijkhuizen MA, Ahmed T, Roos N. Factors affecting the micronutrient status of adolescent girls living in complex agro-aquatic ecological zones of Bangladesh. Sci Rep. 2023 Apr 24;13(1):6631. doi: 10.1038/s41598-023-33636-8.

    PubMed 37095307

  • Grieve E, Mamun AA, de Roos B, Barman BK, Ara G, Roos N, Pounds A, Sneddon AA, Murray F, Ahmed T, Little DC. Adolescent girls in aquaculture ecozones at risk of nutrient deficiency in Bangladesh development and validation of an integrated metric. BMC Public Health. 2023 Feb 28;23(1):405. doi: 10.1186/s12889-023-15175-z.

    PubMed 36855076

Questions about this trial

What is this clinical trial studying?

An observational study of Nutritional Status and Micronutrient Status, run by University of Copenhagen at 1 site in Bangladesh.

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 2 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: opening soon, as of the sponsor's last update on 6 May 2026. 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 Bangladesh. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nanna Roos, PhD (+45 3532 0829, nexs@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Omega-3 status (time frame: One sampling point between April and August 2026). The study lists 7 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 NCT07541742, which also lists 2 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 6 May 2026.

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