Docosahexaenoic Acid Content of the ParticipantsVITAMINNCT07042009
Effectiveness of Nutritional Resources for Milk Donors
A study testing Nutritional resources and Milk docosahexaenoic acid levels in people with Docosahexaenoic Acid Content of the Participants and Docosahexaenoic Acid Content of the Breast Milk, run by University of Roehampton at 1 site in United Kingdom.
Trial summary
Maternal diet influences breast milk nutritional profile; however, a national survey undertaken by the researchers revealed that non-for-profit donor milk banks in the U.K. do not provide specific dietary information to donors. Moreover, the researchers have shown that donor milk in the U.K. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Docosahexaenoic Acid Content of the Participants, Docosahexaenoic Acid Content of the Breast Milk
- What is being tested?
- Nutritional resources and Milk docosahexaenoic acid levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Apr 2026to 11 Feb 2027
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New donors from the Countess of Chester Hospital milk bank
Who cannot join
- Insufficient comprehension of English to understand the information sheet and consent form and complete the questionnaires
- Currently taking omega-3 PUFA dietary supplements providing greater than 200 mg DHA per day
- Body Mass Index (BMI) ≥30 kg/m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jacqueline Chan, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Chester Milk Bank
Chester
Laura Atherton, + 44 (0)1244 362 226, laura.atherton4@nhs.net
About this study
Official title: inVestigating the effectIveness of nuTritionAl Information Resources for MIlk doNors
Maternal diet influences breast milk nutritional profile; however, a national survey undertaken by the researchers revealed that non-for-profit donor milk banks in the U.K. do not provide specific dietary information to donors. Moreover, the researchers have shown that donor milk in the U.K. provides very low levels of the omega-3 and omega-6 polyunsaturated fatty acids (PUFAs), docosahexaenoic acid (DHA) and arachidonic acid, respectively. These are essential for brain development and immune system function, and preterm infants receiving donor milk do not receive sufficient levels of these nutrients. There is therefore an urgent need to develop nutritional guidelines and resources for milk donors.
Following a systematic review the researchers developed evidence-based nutritional information resources for donors, which would also be applicable more generally to lactating mothers. Those resources were developed in consultation with donors, and healthcare professionals, including dietitians and lactation consultants.
Researchers will evaluate the effectiveness of these resources in terms of acceptance and compliance, and also changes in milk DHA content. The researchers will also assess whether providing feedback on individual's milk DHA content increases milk DHA levels. If successful these resources will be introduced into milk banks across the U.K., and promoted to the wider breastfeeding community.
Read the detailed description
This is an open label intervention study which lasts eight weeks, but the researchers will operate a rolling recruitment approach, and aim to recruit on average eight participants per month over eight months, to meet the target of 60 participants. Donors will be recruited from the Countess of Chester Hospital milk bank, which is the largest milk bank in England, and typically recruits around 30 to 35 new donors per month, and the researchers are aiming for an approximate 25% conversion rate. At recruitment participants will complete a validated omega-3 polyunsaturated fatty acid (PUFA) Food Frequency Questionnaire (FFQ), provide a bloodspot sample for PUFA analysis, and 1 mL of manually expressed breast milk, which will be expressed at home and brought in by the donors. The bloodspot PUFA analysis will quantify blood docosahexaenoic acid (DHA and eicosapentaenoic acid (EPA) content, which will be used to assess baseline and endpoint participant omega-3 PUFA levels. Then follows the nutritional consultation where the nutritional information resources are provided to the participants. Participants are instructed on how to complete a three-day photo diet diary, to be submitted via a mobile phone application, such as FoodView at the start, middle and end of the study, and how to collect milk drop samples on filter paper. These milk drop samples are collected in weeks 1 and 5, as a drop on a filter paper and posted for analysis. Participants are then randomised so that half will be sent the results of this milk spot analysis, and half will not. After eight weeks there is an endpoint visit, with exit questionnaire and sample collections as at baseline.
The baseline and endpoint milk samples will be manually expressed, and where possible, expressions from more than one time-point on the day will be pooled to allow for differences in milk expression over 24 hours. Samples will be frozen at -70⁰C on the day of expression and shipped on dry ice for analysis. The blood pin prick and drop of breast milk samples will be collected as single drops onto filter paper impregnated with an antioxidant to preserve PUFAs. The paper will be air-dried, wrapped in foil, sealed in polythene bag and stored until analysis. Fatty acids from all samples will be measured by gas chromatography with flame ionisation detector. There is a good correlation between the results of liquid and dried milk spot analysis; however, the dried spot samples are only reported as percentage of total fatty acids and so will primarily be used to provide feedback to the participants. Whereas the liquid milk samples will be reported in absolute amounts as well as percent of the total fatty acids, which allows for a more complete understanding of the composition. Any surplus milk samples will be stored at -70⁰C, where they may be used in future analyses of lipid or nutrient content.
The omega-3 PUFA FFQ will be completed and analysed as per the researchers previous research. For the photo-diet diary, at the initial encounter, each participant will be instructed on how to take the images of foods and beverages over one day. All will use the participants own mobile phone with built-in camera and will use a mobile phone application, such as FoodView. Different meal components will be kept separate on the plate and participants instructed to take one picture per meal. Extra food portions or leftovers are documented by additional pictures. The photo-diaries are taken for two mid-week and one weekend days and submitted via the app for subsequent nutrient analysis using Dietplan software by the research team.
- Conditions
- Docosahexaenoic Acid Content of the Participants, Docosahexaenoic Acid Content of the Breast Milk
- Being tested
- Nutritional resources, Milk docosahexaenoic acid levels
- Keywords
- omega-3 fatty acids, donor human milk, human milk bank, preterm infants, DHA, docosahexaenoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional resourcesOther
The participants will be provided with the nutritional resources only.
Milk docosahexaenoic acid levelsOther
The participants will be provided with information on the levels of docosahexaenoic acid in their breast milk.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional resources | Experimental | Participants in this arm will be provided with the nutritional resources. Receives: Other: Nutritional resources |
| Nutritional resources and breast milk DHA content | Experimental | Participants in this arm will be provided with the nutritional resources and feedback on their milk docosahexaenoic acid (DHA) levels Receives: Other: Nutritional resources; Other: Milk docosahexaenoic acid levels |
| Control | No intervention | Participants in this arm will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content of omega-3 fatty acids in the participants diet
The omega-3 fatty acid content of the participants diet will be assessed from three-day photo-diet diaries taken at the start and end of the study. The participants will use their own mobile phone with a phone application, such as FoodView to record their meals. The omega-3 fatty acid values for alpha-linolenic acid, eicosapentaenoic acid and docosahexaenoic will then be calculated in mg/day from these images using nutrient analysis software, such as Dietplan, and intake levels will be compared between the baseline and endpoint values.
Measured: 8 weeks
Secondary outcomes (2)
Concentration of docosahexaenoic acid in the participants breast milk
The concentration of docosahexaenoic acid in the participants breast milk will be measured by gas chromatography from samples taken at the start and end of the study.
Measured: 8 weeks
Concentration of omega-3 fatty acids in the participants blood
The omega-3 fatty acid concentration of the participants non-fasted blood will be assessed by measuring the docosahexaenoic and eicosapentaenoic acid levels from pin-prick whole-blood samples taken at the start and end of the study. The samples will be analysed by gas chromatography.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start2 Apr 2026
- Primary completion11 Feb 2027 (estimated)
- Study completion11 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Docosahexaenoic Acid Content of the ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Collaborators
- Countess of Chester NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Simon Dyall, University of Roehampton
- Investigators
- Simon Dyall, PhD, Study chair, University of RoehamptonYvonne Jeanes, PhD, Study director, British Dietetic Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042009
- Sponsor's protocol ID
- SD002
- Acronym
- VITAMIN
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nessel I, De Rooy L, Khashu M, Murphy JL, Dyall SC. Long-Chain Polyunsaturated Fatty Acids and Lipid Peroxidation Products in Donor Human Milk in the United Kingdom: Results From the LIMIT 2-Centre Cross-Sectional Study. JPEN J Parenter Enteral Nutr. 2020 Nov;44(8):1501-1509. doi: 10.1002/jpen.1773. Epub 2020 Feb 11.
PubMed 32048312Falize C, Savage M, Jeanes YM, Dyall SC. Evaluating the relationship between the nutrient intake of lactating women and their breast milk nutritional profile: a systematic review and narrative synthesis. Br J Nutr. 2024 Apr 14;131(7):1196-1224. doi: 10.1017/S0007114523002775. Epub 2023 Dec 6.
PubMed 38053371De Rooy L, Hamdallah H, Dyall SC. Extremely preterm infants receiving standard care receive very low levels of arachidonic and docosahexaenoic acids. Clin Nutr. 2017 Dec;36(6):1593-1600. doi: 10.1016/j.clnu.2016.09.033. Epub 2016 Oct 8.
PubMed 27756480
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- inVestigating the effectIveness of nuTritionAl Information Resources for MIlk doNors
- ClinicalTrials.gov ID
- NCT07042009
- Acronym / sponsor ID
- VITAMIN / SD002
- Conditions
- Docosahexaenoic Acid Content of the Participants, Docosahexaenoic Acid Content of the Breast Milk
- Keywords
- omega-3 fatty acids, donor human milk, human milk bank, preterm infants, DHA, docosahexaenoic acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Collaborators
- Countess of Chester NHS Foundation Trust
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 11 Feb 2027 (estimated)
- Study completion
- 11 Feb 2027 (estimated)
- First posted
- 27 Jun 2025 (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.
Maternal diet influences breast milk nutritional profile; however, a national survey undertaken by the researchers revealed that non-for-profit donor milk banks in the U.K. do not provide specific dietary information to donors. Moreover, the researchers have shown that donor milk in the U.K. provides very low levels of the omega-3 and omega-6 polyunsaturated fatty acids (PUFAs), docosahexaenoic acid (DHA) and arachidonic acid, respectively. These are essential for brain development and immune system function, and preterm infants receiving donor milk do not receive sufficient levels of these nutrients. There is therefore an urgent need to develop nutritional guidelines and resources for milk donors.
Following a systematic review the researchers developed evidence-based nutritional information resources for donors, which would also be applicable more generally to lactating mothers. Those resources were developed in consultation with donors, and healthcare professionals, including dietitians and lactation consultants.
Researchers will evaluate the effectiveness of these resources in terms of acceptance and compliance, and also changes in milk DHA content. The researchers will also assess whether providing feedback on individual's milk DHA content increases milk DHA levels. If successful these resources will be introduced into milk banks across the U.K., and promoted to the wider breastfeeding community.
Detailed description
This is an open label intervention study which lasts eight weeks, but the researchers will operate a rolling recruitment approach, and aim to recruit on average eight participants per month over eight months, to meet the target of 60 participants. Donors will be recruited from the Countess of Chester Hospital milk bank, which is the largest milk bank in England, and typically recruits around 30 to 35 new donors per month, and the researchers are aiming for an approximate 25% conversion rate. At recruitment participants will complete a validated omega-3 polyunsaturated fatty acid (PUFA) Food Frequency Questionnaire (FFQ), provide a bloodspot sample for PUFA analysis, and 1 mL of manually expressed breast milk, which will be expressed at home and brought in by the donors. The bloodspot PUFA analysis will quantify blood docosahexaenoic acid (DHA and eicosapentaenoic acid (EPA) content, which will be used to assess baseline and endpoint participant omega-3 PUFA levels. Then follows the nutritional consultation where the nutritional information resources are provided to the participants. Participants are instructed on how to complete a three-day photo diet diary, to be submitted via a mobile phone application, such as FoodView at the start, middle and end of the study, and how to collect milk drop samples on filter paper. These milk drop samples are collected in weeks 1 and 5, as a drop on a filter paper and posted for analysis. Participants are then randomised so that half will be sent the results of this milk spot analysis, and half will not. After eight weeks there is an endpoint visit, with exit questionnaire and sample collections as at baseline.
The baseline and endpoint milk samples will be manually expressed, and where possible, expressions from more than one time-point on the day will be pooled to allow for differences in milk expression over 24 hours. Samples will be frozen at -70⁰C on the day of expression and shipped on dry ice for analysis. The blood pin prick and drop of breast milk samples will be collected as single drops onto filter paper impregnated with an antioxidant to preserve PUFAs. The paper will be air-dried, wrapped in foil, sealed in polythene bag and stored until analysis. Fatty acids from all samples will be measured by gas chromatography with flame ionisation detector. There is a good correlation between the results of liquid and dried milk spot analysis; however, the dried spot samples are only reported as percentage of total fatty acids and so will primarily be used to provide feedback to the participants. Whereas the liquid milk samples will be reported in absolute amounts as well as percent of the total fatty acids, which allows for a more complete understanding of the composition. Any surplus milk samples will be stored at -70⁰C, where they may be used in future analyses of lipid or nutrient content.
The omega-3 PUFA FFQ will be completed and analysed as per the researchers previous research. For the photo-diet diary, at the initial encounter, each participant will be instructed on how to take the images of foods and beverages over one day. All will use the participants own mobile phone with built-in camera and will use a mobile phone application, such as FoodView. Different meal components will be kept separate on the plate and participants instructed to take one picture per meal. Extra food portions or leftovers are documented by additional pictures. The photo-diaries are taken for two mid-week and one weekend days and submitted via the app for subsequent nutrient analysis using Dietplan software by the research team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutritional resources | Experimental | Other: Nutritional resourcesParticipants in this arm will be provided with the nutritional resources. |
| Nutritional resources and breast milk DHA content | Experimental | Other: Nutritional resources, Other: Milk docosahexaenoic acid levelsParticipants in this arm will be provided with the nutritional resources and feedback on their milk docosahexaenoic acid (DHA) levels |
| Control | No intervention | –Participants in this arm will receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New donors from the Countess of Chester Hospital milk bank
Key exclusion criteria (3 listed)
- Insufficient comprehension of English to understand the information sheet and consent form and complete the questionnaires
- Currently taking omega-3 PUFA dietary supplements providing greater than 200 mg DHA per day
- Body Mass Index (BMI) ≥30 kg/m2
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 |
|---|---|---|
| Nutritional resourcesThe participants will be provided with the nutritional resources only. | Other | Nutritional resources, Nutritional resources and breast milk DHA content |
| Milk docosahexaenoic acid levelsThe participants will be provided with information on the levels of docosahexaenoic acid in their breast milk. | Other | Nutritional resources and breast milk DHA content |
Primary outcome
Content of omega-3 fatty acids in the participants diet
Time frame: 8 weeks
The omega-3 fatty acid content of the participants diet will be assessed from three-day photo-diet diaries taken at the start and end of the study. The participants will use their own mobile phone with a phone application, such as FoodView to record their meals. The omega-3 fatty acid values for alpha-linolenic acid, eicosapentaenoic acid and docosahexaenoic will then be calculated in mg/day from these images using nutrient analysis software, such as Dietplan, and intake levels will be compared between the baseline and endpoint values.
2 secondary outcomes
Concentration of docosahexaenoic acid in the participants breast milk
Time frame: 8 weeks
Concentration of omega-3 fatty acids in the participants blood
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 32048312Nessel I, De Rooy L, Khashu M, Murphy JL, Dyall SC. Long-Chain Polyunsaturated Fatty Acids and Lipid Peroxidation Products in Donor Human Milk in the United Kingdom: Results From the LIMIT 2-Centre Cross-Sectional Study. JPEN J Parenter Enteral Nutr. 2020 Nov;44(8):1501-1509. doi: 10.1002/jpen.1773. Epub 2020 Feb 11.
- Background: PubMed 38053371Falize C, Savage M, Jeanes YM, Dyall SC. Evaluating the relationship between the nutrient intake of lactating women and their breast milk nutritional profile: a systematic review and narrative synthesis. Br J Nutr. 2024 Apr 14;131(7):1196-1224. doi: 10.1017/S0007114523002775. Epub 2023 Dec 6.
- Background: PubMed 27756480De Rooy L, Hamdallah H, Dyall SC. Extremely preterm infants receiving standard care receive very low levels of arachidonic and docosahexaenoic acids. Clin Nutr. 2017 Dec;36(6):1593-1600. doi: 10.1016/j.clnu.2016.09.033. Epub 2016 Oct 8.
- Individual participant dataSharing planned: No
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.
Jacqueline Chan, PhD contact
Simon Dyall, PhD study chair
University of Roehampton
Yvonne Jeanes, PhD study director
British Dietetic Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional resources and Milk docosahexaenoic acid levels in people with Docosahexaenoic Acid Content of the Participants and Docosahexaenoic Acid Content of the Breast Milk, run by University of Roehampton at 1 site in United Kingdom.
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 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: looking for participants now, as of the sponsor's last update on 4 Sep 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 United Kingdom. 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 Coralie Falize (+44 (0)2083923538, falizec@roehampton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content of omega-3 fatty acids in the participants diet (time frame: 8 weeks). 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 NCT07042009, which also lists 3 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 4 Sep 2026.