Oxidative StressPhase 2/3NCT01947426
Effect of Mother DHA Supplementation on Term Newborn.
A Phase 2/3 study testing DHA Supplementation in people with Oxidative Stress and Inflammation, run by Universidad de Granada at 1 site in Spain.
Trial summary
In the present study, we evaluate the effect of the mother suplementación with DHA during the gestation and lactation on diverse aspects of the development of newborn. The effect on the oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development was studied. Read more about this study
- Who is it for?
- Ages Up to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Inflammation, Infant Development
- What is being tested?
- DHA Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2008to Apr 2011
- Phase
- Phase 2/3
- 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 Up to 40 years
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Consent
- mother with normal gestation.
Who cannot join
- Risk factors during gestation.
- Lactose intolerance
- systemic illness.
- Kwashiorkor.
- Metabolic illness.
- Foetal pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Maternal Supplementation With DHA During Pregnancy and Lactation on the Development of the Term Newborn
In the present study, we evaluate the effect of the mother suplementación with DHA during the gestation and lactation on diverse aspects of the development of newborn. The effect on the oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development was studied. Women will in the sixth month of pregnancy, consume a diet balanced during last 3 months of pregnancy and the whole lactation. In addition the women will divide in two groups: one will receive a supplement of docosahexaenoic acid (DHA) to evaluate the effects on the development of the newborn child; whereas another group will receive a placebo. Different samples of blood of the mother and of mother milk will be taken and we will correlating her lipidic profile with the brain development of the newborn child, evaluated by different tests.
Read the detailed description
The sample will be 120 volunteers that will be enrolled in the services of Gynaecology of the infantile Hospital of Granada. The pregnant women will be assigned from random form to one of 2 groups that are described later:
Group A: balanced diet Mediterranean, intake of 2 glasses / day of the dairy drink control.
Group B: balanced Mediterranean diet together with the consumption of 400mg/day of DHA in the dairy product (2 glasses / day). The dairy products will be distributed in white packages without any indication that reflects the type of product that contains (double blind). Every volunteer will be assigned a key that guarantees the confidentiality of their analytical values.
The dietary intervention will begin in the sixth month of pregnancy and will conclude to the third month of lactation (though there will improve itself the importance of a mother lactation up to 6 month postpartum). There will be obtained samples of blood (5 mL) of the mothers in the moment of the capture, in the childbirth and to 3 postpartum months. There will take a sample of blood of umbilical cord (5mL) in the moment of the childbirth (vein and artery). In addition there will take a sample of blood of the child (5mL) to 2.5 months. There will take also samples of mother milk (10mL), concretely of colostrum (2-3 postpartum days) and of mature(ripe) milk to 1, 2, 3 months. The samples will be preserved in freezer of-80ºC and sent to the different laboratories due preserved participants in order that there does not break the cold chain ( dry ice). In the first year of life of the child there will be practised tests of motive and cognitive development (Bayley's test and Fagan's test) in order to evaluate the influence of the dietetic intervention on the mother in the development of the child.
- Conditions
- Oxidative Stress, Inflammation, Infant Development
- Being tested
- DHA Supplementation, Control (milk without DHA)
- Keywords
- DHA, term neonates, mother milk
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA SupplementationDietary supplement
Also called Docosahexaenoic acid
mothers consuming 400 mg of DHA/day and their neonates
Control (milk without DHA)Dietary supplement
Also called Placebo group
mothers consuming placebo product and their neonates
| Study group | Role | What they receive |
|---|---|---|
| DHA supplementation | Experimental | mother consuming 400 mg/day of DHA and tehir neonates Receives: Dietary Supplement: DHA Supplementation |
| Control (milk without DHA) | Placebo comparator | Mothers comsuming placebo and their neonates Receives: Dietary Supplement: Control (milk without DHA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Visual Development of newborn
Visual Evoked Potentials
Measured: Change from Baseline at 12 months of life
Secondary outcomes (3)
Change of bone turnover biomarkers in blood samples during supplementation
indicators of Bone turnover in the mother and their child
Measured: Change from Baseline after supplementation (2,5 months)
Change of oxidative stress parameters in mother milk samples during supplementation
oxidative stress parameters (indicators of oxidative stress to lipids and proteins and antioxidant defense)
Measured: Change from Baseline after supplementation (2,5 months)
Motor and cognitive development of newborn
Bayleys test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Puleva Biotech
- Responsible party
- Principal investigator, Julio J. Ochoa, Universidad de Granada
- Investigators
- Julio J Ochoa, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947426
- Sponsor's protocol ID
- C3565-00
- Other IDs
- C3565-00
- Status last verified
- Sep 2013
- First submitted
- 4 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hurtado JA, Iznaola C, Pena M, Ruiz J, Pena-Quintana L, Kajarabille N, Rodriguez-Santana Y, Sanjurjo P, Aldamiz-Echevarria L, Ochoa J, Lara-Villoslada F; NUGELA Group. Effects of Maternal Omega-3 Supplementation on Fatty Acids and on Visual and Cognitive Development. J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):472-80. doi: 10.1097/MPG.0000000000000864.
PubMed 25988553
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Supplementation With DHA During Pregnancy and Lactation on the Development of the Term Newborn
- ClinicalTrials.gov ID
- NCT01947426
- Acronym / sponsor ID
- C3565-00
- Conditions
- Oxidative Stress, Inflammation, Infant Development
- Keywords
- DHA, term neonates, mother milk
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Puleva Biotech
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Sep 2013 (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.
In the present study, we evaluate the effect of the mother suplementación with DHA during the gestation and lactation on diverse aspects of the development of newborn. The effect on the oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development was studied. Women will in the sixth month of pregnancy, consume a diet balanced during last 3 months of pregnancy and the whole lactation. In addition the women will divide in two groups: one will receive a supplement of docosahexaenoic acid (DHA) to evaluate the effects on the development of the newborn child; whereas another group will receive a placebo. Different samples of blood of the mother and of mother milk will be taken and we will correlating her lipidic profile with the brain development of the newborn child, evaluated by different tests.
Detailed description
The sample will be 120 volunteers that will be enrolled in the services of Gynaecology of the infantile Hospital of Granada. The pregnant women will be assigned from random form to one of 2 groups that are described later:
Group A: balanced diet Mediterranean, intake of 2 glasses / day of the dairy drink control.
Group B: balanced Mediterranean diet together with the consumption of 400mg/day of DHA in the dairy product (2 glasses / day). The dairy products will be distributed in white packages without any indication that reflects the type of product that contains (double blind). Every volunteer will be assigned a key that guarantees the confidentiality of their analytical values.
The dietary intervention will begin in the sixth month of pregnancy and will conclude to the third month of lactation (though there will improve itself the importance of a mother lactation up to 6 month postpartum). There will be obtained samples of blood (5 mL) of the mothers in the moment of the capture, in the childbirth and to 3 postpartum months. There will take a sample of blood of umbilical cord (5mL) in the moment of the childbirth (vein and artery). In addition there will take a sample of blood of the child (5mL) to 2.5 months. There will take also samples of mother milk (10mL), concretely of colostrum (2-3 postpartum days) and of mature(ripe) milk to 1, 2, 3 months. The samples will be preserved in freezer of-80ºC and sent to the different laboratories due preserved participants in order that there does not break the cold chain ( dry ice). In the first year of life of the child there will be practised tests of motive and cognitive development (Bayley's test and Fagan's test) in order to evaluate the influence of the dietetic intervention on the mother in the development of the child.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA supplementation | Experimental | Dietary Supplement: DHA Supplementationmother consuming 400 mg/day of DHA and tehir neonates |
| Control (milk without DHA) | Placebo comparator | Dietary Supplement: Control (milk without DHA)Mothers comsuming placebo and their neonates |
Who may qualify
- Ages
- Up to 40 years
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Consent
- mother with normal gestation.
Key exclusion criteria (6 listed)
- Risk factors during gestation.
- Lactose intolerance
- systemic illness.
- Kwashiorkor.
- Metabolic illness.
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 |
|---|---|---|
| DHA SupplementationAlso: Docosahexaenoic acidmothers consuming 400 mg of DHA/day and their neonates | Dietary supplement | DHA supplementation |
| Control (milk without DHA)Also: Placebo groupmothers consuming placebo product and their neonates | Dietary supplement | Control (milk without DHA) |
Primary outcome
Change of Visual Development of newborn
Time frame: Change from Baseline at 12 months of life
Visual Evoked Potentials
3 secondary outcomes
Change of bone turnover biomarkers in blood samples during supplementation
Time frame: Change from Baseline after supplementation (2,5 months)
Change of oxidative stress parameters in mother milk samples during supplementation
Time frame: Change from Baseline after supplementation (2,5 months)
Motor and cognitive development of newborn
Time frame: 12 months
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 20 Sep 2013.
- Derived from this study: PubMed 25988553Hurtado JA, Iznaola C, Pena M, Ruiz J, Pena-Quintana L, Kajarabille N, Rodriguez-Santana Y, Sanjurjo P, Aldamiz-Echevarria L, Ochoa J, Lara-Villoslada F; NUGELA Group. Effects of Maternal Omega-3 Supplementation on Fatty Acids and on Visual and Cognitive Development. J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):472-80. doi: 10.1097/MPG.0000000000000864.
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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.
Julio J Ochoa principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DHA Supplementation in people with Oxidative Stress and Inflammation, run by Universidad de Granada at 1 site in Spain.
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 6 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 20 Sep 2013. 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of Visual Development of newborn (time frame: Change from Baseline at 12 months of life). 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 NCT01947426, which also lists 1 linked publication.
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 20 Sep 2013.