PrematureDHARMANCT01062373
Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns
A study testing Supplementation of lactating mothers who has delivered prematurely with DHA in people with Premature, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother… Read more about this study
- Who is it for?
- Ages 1 day to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature
- What is being tested?
- Supplementation of lactating mothers who has delivered prematurely with DHA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Jun 2012
- 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 1 day to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Childbirth between 34 and 35 GA
- Breast-feeding
- Caucasian
- Affiliation to social security
- Obtained consent from mother, and parents for the child
- Mother with balanced diet
- No allergy to eggs
- Single pregnancy
Who cannot join
- Allergy to egg
- Unbalanced diet
- Diabetes
- Known digestive disease
- Counter-indication with breast-feeding
- Cigarettes (more than 5 per day)
- Alcoholism (daily consumption of alcohol)
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine néonatale, Hôpital de la Conception
Marseille, 13385
About this study
Official title: Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk
Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. We will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and n-6 fatty acids pathways.
- Conditions
- Premature
- Being tested
- Supplementation of lactating mothers who has delivered prematurely with DHA
- Keywords
- Premature Newborns, Human Milk, DHA, Mother-child
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation of lactating mothers who has delivered prematurely with DHADietary supplement
Also called TG-DHA from Decola compagny in Belgium: oil of microalgae saled by Martek US compagny containing triglycerides enriched in DHA ; code 139 890
Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by TG-DHA from Decola (products from Martek) (two soft capsules per day)
Supplementation of lactating mothers who has delivered prematurely with DHADietary supplement
Also called GPL-DHA from Application Santé des Lipides BioParc Vichy Hauterive France: dry yolk egg powder containing glycerophospholipids enriched in DHA code AA 22/12/11
Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by GPL-DHA from ASL (10 g per day) (two soft capsules per day)
| Study group | Role | What they receive |
|---|---|---|
| TG-DHA | Active comparator | TG-DHA: lactating mothers and their newborn with mothers supplemented with Triglyceride enriched in docosahexaenoic acid Receives: Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHA |
| Control | No intervention | Control: lactating mothers and their newborn with no supplementation given to the mother |
| GPL-DHA | Experimental | GPL-DHA: lactating mothers and their newborn with mothers supplemented with Glycerophospholipid enriched in docosahexaenoic acid Receives: Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To improve PUFA status in premature newborns
Measured: 30 days
Secondary outcomes (6)
PUFA in human milk (HM) and mothers
Measured: 6 months
Impact on HM bioactives
Measured: 6 months
Change in inflammation and oxydative stress
Measured: 6 months
Genes expression in newborns
Measured: 6 months
Link between mothers genetics and HM DHA level
Measured: 6 months
Newborn survey at 6 month-old
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: difficulties of recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Véronique Millet, MD, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062373
- Sponsor's protocol ID
- C08-20
- Other IDs
- 2009-A00006-51
- Acronym
- DHARMA
- Status last verified
- Jan 2012
- First submitted
- 3 Feb 2010
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk
- ClinicalTrials.gov ID
- NCT01062373
- Acronym / sponsor ID
- DHARMA / C08-20
- Conditions
- Premature
- Keywords
- Premature Newborns, Human Milk, DHA, Mother-child
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties of recruitement
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Feb 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Feb 2010 (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.
Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. We will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and n-6 fatty acids pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TG-DHA | Active comparator | Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHATG-DHA: lactating mothers and their newborn with mothers supplemented with Triglyceride enriched in docosahexaenoic acid |
| Control | No intervention | –Control: lactating mothers and their newborn with no supplementation given to the mother |
| GPL-DHA | Experimental | Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHAGPL-DHA: lactating mothers and their newborn with mothers supplemented with Glycerophospholipid enriched in docosahexaenoic acid |
Who may qualify
- Ages
- 1 day to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Childbirth between 34 and 35 GA
- Breast-feeding
- Caucasian
- Affiliation to social security
- Obtained consent from mother, and parents for the child
Key exclusion criteria (8 listed)
- Allergy to egg
- Unbalanced diet
- Diabetes
- Known digestive disease
- Counter-indication with breast-feeding
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 |
|---|---|---|
| Supplementation of lactating mothers who has delivered prematurely with DHAAlso: TG-DHA from Decola compagny in Belgium: oil of microalgae saled by Martek US compagny containing triglycerides enriched in DHA ; code 139 890Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by TG-DHA from Decola (products from Martek) (two soft capsules per day) | Dietary supplement | TG-DHA |
| Supplementation of lactating mothers who has delivered prematurely with DHAAlso: GPL-DHA from Application Santé des Lipides BioParc Vichy Hauterive France: dry yolk egg powder containing glycerophospholipids enriched in DHA code AA 22/12/11Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by GPL-DHA from ASL (10 g per day) (two soft capsules per day) | Dietary supplement | GPL-DHA |
Primary outcome
To improve PUFA status in premature newborns
Time frame: 30 days
6 secondary outcomes
PUFA in human milk (HM) and mothers
Time frame: 6 months
Impact on HM bioactives
Time frame: 6 months
Change in inflammation and oxydative stress
Time frame: 6 months
Genes expression in newborns
Time frame: 6 months
Link between mothers genetics and HM DHA level
Time frame: 6 months
Newborn survey at 6 month-old
Time frame: 6 months
Results and safety
The study was stopped early (reason given: difficulties of recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
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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.
Véronique Millet, MD, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementation of lactating mothers who has delivered prematurely with DHA in people with Premature, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 8 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: stopped early, as of the sponsor's last update on 27 Sep 2012. 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 France. 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 was stopped early (reason given: difficulties of recruitement). Results are not available in the source record.
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?
To improve PUFA status in premature newborns (time frame: 30 days). 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 Sep 2012.