Perinatal DHA and Folate StatusNUHEALNCT01180933
Fish Oil and Folate Supplementation During Pregnancy
A study testing fish oil, folate and fish oil + folate in people with Perinatal DHA and Folate Status and Neurological Development, run by Ludwig-Maximilians - University of Munich at 3 sites in 3 countries.
Trial summary
Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal DHA and Folate Status, Neurological Development
- What is being tested?
- fish oil, folate and fish oil + folate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2001to Mar 2013
- 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 18 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy
- gestation <20 week at enrollment
- intention to deliver in one of the study centers
- body weight at time of enrollment from 50 kg to 92 kg
Who cannot join
- serious chronic illness (eg, diabetes, hepatitis)
- use fish oil supplements since the beginning of pregnancy
- use of folate or vitamin B-12 supplements after gestation week 16
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University
Munich, 80337
About this study
Official title: Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy
Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood.
Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.
- Being tested
- fish oil, folate, fish oil + folate, placebo
- Keywords
- docosahexaenoic acid, folate, neurological development, allergies, long term consequences for the offspring, allergy risk
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oilDietary supplement
400 mg of DHA and 150 mg of eicosapentaenoic acid per day
folateDietary supplement
400 µg per day
fish oil + folateDietary supplement
500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
placeboDietary supplement
only vitamins and minerals as recommended, but no fish oil or folate
| Study group | Role | What they receive |
|---|---|---|
| fish oil | Experimental | the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA and 150 eicosapentaenoic acid per day from gestational week 22 until delivery Receives: Dietary Supplement: fish oil |
| folate | Experimental | the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 400 µg folate (methyltetrahydrofolate)per day from gestational week 22 until delivery Receives: Dietary Supplement: folate |
| fish oil + folate | Experimental | the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA, 150 mg eicosapentaenoic acid and 400 µg MTHF per day from gestational week 22 until delivery Receives: Dietary Supplement: fish oil + folate |
| placebo | Placebo comparator | the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood
the biochemical efficacy of supplementation during pregnancy is tested by measuring the DHA content of cord blood phospholipids, as direct supplementation (fish oil) or increased perfusion of the placenta (MTHF) could both influence this parameter
Measured: labour
Secondary outcomes (5)
neurological and cognitive development of the offspring
non invasive, age adequate, tests of neurological and cognitive function are performed at various ages of the offspring
Measured: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years
weight development
body weight (including weight of fat and non fat mass by bioelectrical impedance at later ages) is determined
Measured: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
height
body height is measured at ages 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
Measured: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
life style and diet
information on medical history, life sytyle and dietary habits is collected via questionnaires and non invasivly collected of biological samples (urine, cheek cells)
Measured: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years
electroencephalography (EEG)
at age 8 years and 9.5 years an EEG is obtained while the children are performing defined tests
Measured: age 8 years and 9.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startNov 2001
- Primary completionAug 2003
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Perinatal DHA and Folate StatusStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Investigators
- Berthold Koletzko, Prof., Study director, Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180933
- Sponsor's protocol ID
- 01111
- Acronym
- NUHEAL
- Status last verified
- Jun 2014
- First submitted
- 11 Aug 2010
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Krauss-Etschmann S, Shadid R, Campoy C, Hoster E, Demmelmair H, Jimenez M, Gil A, Rivero M, Veszpremi B, Decsi T, Koletzko BV; Nutrition and Health Lifestyle (NUHEAL) Study Group. Effects of fish-oil and folate supplementation of pregnant women on maternal and fetal plasma concentrations of docosahexaenoic acid and eicosapentaenoic acid: a European randomized multicenter trial. Am J Clin Nutr. 2007 May;85(5):1392-400. doi: 10.1093/ajcn/85.5.1392.
PubMed 17490978Catena A, Munoz-Machicao JA, Torres-Espinola FJ, Martinez-Zaldivar C, Diaz-Piedra C, Gil A, Haile G, Gyorei E, Molloy AM, Decsi T, Koletzko B, Campoy C. Folate and long-chain polyunsaturated fatty acid supplementation during pregnancy has long-term effects on the attention system of 8.5-y-old offspring: a randomized controlled trial. Am J Clin Nutr. 2016 Jan;103(1):115-27. doi: 10.3945/ajcn.115.109108. Epub 2015 Nov 11.
PubMed 26561619Campoy C, Escolano-Margarit MV, Ramos R, Parrilla-Roure M, Csabi G, Beyer J, Ramirez-Tortosa MC, Molloy AM, Decsi T, Koletzko BV. Effects of prenatal fish-oil and 5-methyltetrahydrofolate supplementation on cognitive development of children at 6.5 y of age. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1880S-1888S. doi: 10.3945/ajcn.110.001107. Epub 2011 Aug 17.
PubMed 21849596Escolano-Margarit MV, Ramos R, Beyer J, Csabi G, Parrilla-Roure M, Cruz F, Perez-Garcia M, Hadders-Algra M, Gil A, Decsi T, Koletzko BV, Campoy C. Prenatal DHA status and neurological outcome in children at age 5.5 years are positively associated. J Nutr. 2011 Jun;141(6):1216-23. doi: 10.3945/jn.110.129635. Epub 2011 Apr 27.
PubMed 21525247
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy
- ClinicalTrials.gov ID
- NCT01180933
- Acronym / sponsor ID
- NUHEAL / 01111
- Keywords
- docosahexaenoic acid, folate, neurological development, allergies, long term consequences for the offspring, allergy risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Nov 2001
- Primary completion
- Aug 2003 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Aug 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.
Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood.
Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fish oil | Experimental | Dietary Supplement: fish oilthe participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA and 150 eicosapentaenoic acid per day from gestational week 22 until delivery |
| folate | Experimental | Dietary Supplement: folatethe participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 400 µg folate (methyltetrahydrofolate)per day from gestational week 22 until delivery |
| fish oil + folate | Experimental | Dietary Supplement: fish oil + folatethe participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA, 150 mg eicosapentaenoic acid and 400 µg MTHF per day from gestational week 22 until delivery |
| placebo | Placebo comparator | Dietary Supplement: placebothe participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- singleton pregnancy
- gestation <20 week at enrollment
- intention to deliver in one of the study centers
- body weight at time of enrollment from 50 kg to 92 kg
Key exclusion criteria (3 listed)
- serious chronic illness (eg, diabetes, hepatitis)
- use fish oil supplements since the beginning of pregnancy
- use of folate or vitamin B-12 supplements after gestation week 16
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 |
|---|---|---|
| fish oil400 mg of DHA and 150 mg of eicosapentaenoic acid per day | Dietary supplement | fish oil |
| folate400 µg per day | Dietary supplement | folate |
| fish oil + folate500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day | Dietary supplement | fish oil + folate |
| placeboonly vitamins and minerals as recommended, but no fish oil or folate | Dietary supplement | placebo |
Primary outcome
percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood
Time frame: labour
the biochemical efficacy of supplementation during pregnancy is tested by measuring the DHA content of cord blood phospholipids, as direct supplementation (fish oil) or increased perfusion of the placenta (MTHF) could both influence this parameter
5 secondary outcomes
neurological and cognitive development of the offspring
Time frame: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years
weight development
Time frame: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
height
Time frame: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
life style and diet
Time frame: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years
electroencephalography (EEG)
Time frame: age 8 years and 9.5 years
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 30 Jul 2014.
- Results publication: PubMed 17490978Krauss-Etschmann S, Shadid R, Campoy C, Hoster E, Demmelmair H, Jimenez M, Gil A, Rivero M, Veszpremi B, Decsi T, Koletzko BV; Nutrition and Health Lifestyle (NUHEAL) Study Group. Effects of fish-oil and folate supplementation of pregnant women on maternal and fetal plasma concentrations of docosahexaenoic acid and eicosapentaenoic acid: a European randomized multicenter trial. Am J Clin Nutr. 2007 May;85(5):1392-400. doi: 10.1093/ajcn/85.5.1392.
- Derived from this study: PubMed 26561619Catena A, Munoz-Machicao JA, Torres-Espinola FJ, Martinez-Zaldivar C, Diaz-Piedra C, Gil A, Haile G, Gyorei E, Molloy AM, Decsi T, Koletzko B, Campoy C. Folate and long-chain polyunsaturated fatty acid supplementation during pregnancy has long-term effects on the attention system of 8.5-y-old offspring: a randomized controlled trial. Am J Clin Nutr. 2016 Jan;103(1):115-27. doi: 10.3945/ajcn.115.109108. Epub 2015 Nov 11.
- Derived from this study: PubMed 21849596Campoy C, Escolano-Margarit MV, Ramos R, Parrilla-Roure M, Csabi G, Beyer J, Ramirez-Tortosa MC, Molloy AM, Decsi T, Koletzko BV. Effects of prenatal fish-oil and 5-methyltetrahydrofolate supplementation on cognitive development of children at 6.5 y of age. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1880S-1888S. doi: 10.3945/ajcn.110.001107. Epub 2011 Aug 17.
- Derived from this study: PubMed 21525247Escolano-Margarit MV, Ramos R, Beyer J, Csabi G, Parrilla-Roure M, Cruz F, Perez-Garcia M, Hadders-Algra M, Gil A, Decsi T, Koletzko BV, Campoy C. Prenatal DHA status and neurological outcome in children at age 5.5 years are positively associated. J Nutr. 2011 Jun;141(6):1216-23. doi: 10.3945/jn.110.129635. Epub 2011 Apr 27.
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.
Berthold Koletzko, Prof. study director
Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University Munich
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fish oil, folate and fish oil + folate in people with Perinatal DHA and Folate Status and Neurological Development, run by Ludwig-Maximilians - University of Munich at 3 sites in 3 countries.
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 4 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: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Hungary, 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.
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?
percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood (time frame: labour). 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 NCT01180933, which also lists 4 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 30 Jul 2014.