Development and HealthNCT00266305
Fish Oil Supplementation in Lactation
A study testing Fish oil (Dry n-3, BASF) in people with Development and Health, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The main purpose of the study was to examine whether fish oil supplementation of lactating mothers affect infant development during first year of life, focusing on visual and mental development. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Development and Health
- What is being tested?
- Fish oil (Dry n-3, BASF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 1998to Jan 2007
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women with uncomplicated singleton pregnancy
- No metabolic disorders and prepregnancy BMI < 30 kg/m2
- Intention to exclusively breast-feed for 4 mo
- Fish intake below the Danish mean or above 80th percentile (reference group)
Who cannot join
- Pre- or post term delivery (< 37 or > 43 wks of gestation)
- Abnormal weight for gestation (outside 10th-90th percentile range)
- Apgar score 5 min after delivery < 8
- Infant admission to a neonatal department
- If supplementation did not begin within 2 wks after delivery
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of the study was to examine whether fish oil supplementation of lactating mothers affect infant development during first year of life, focusing on visual and mental development. A follow-up studies are conducted in order to see if early intake of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) have any long-term effects on health, primarily immun function and markers of cardiovascular risk.
Read the detailed description
Background:
Studies indicate that infants, who are fed formula without n-3 LCPUFA, have slower visual development than those, who receive n-3 LCPUFA in breast-milk. The mental development seems also to depend on whether infants are breast-fed or not. Long-term health has also been proposed to be affected (The infant origin of adult disease hypothesis). It is not clear whether these differences is due to dietary LCPUFA as comparison of breast-fed and formula-fed infants are complicated by the socio-demographic differences that exist between mother, who choose to breast-feed or not. Recent studies indicate that LCPUFA supplementation of formulas has beneficial effects on the visual acuity and mental abilities of infants. The LCPUFA content of breast-milk varies and this could potentially be of importance for infant development.
Methods:
211 pregnant women with a high (>80 percentile) or low (< mean) fish intake were recruited. After birth mother with low fish intake were randomized to receive 4 g/day of fish oil or olive oil for the first 4 months of the lactation period. 150 mother-infant pairs were followed for 1 year gathering information on maternal n-3 LCPUFA intake and infant development (growth, developmental milestones, visual acuity, cognitive functions and language acquisition). Milk samples were collected at 0, 2, 4 and 9 months and blood samples were taken from the mother and the infant at 4 months of age in order to determine the biochemical effect of the supplementation.
The children were followed-up at 2½ years of age and around 7 years of age. The study is performed in association to the National Birth Cohort.
- Conditions
- Development and Health
- Being tested
- Fish oil (Dry n-3, BASF)
- Keywords
- n-3 LCPUFA, Infant development, Visual acuity, Immune function, Breast milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil (Dry n-3, BASF)Behavioural
5 g/oil daily for the first four month of lactation
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Experimental | Not described Receives: Behavioral: Fish oil (Dry n-3, BASF) |
| Olive oil | Placebo comparator | Control group Receives: Behavioral: Fish oil (Dry n-3, BASF) |
| High fish | No intervention | Reference group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast milk fatty acid composition - 0, 2, 4 and 9 mo
Fatty acid composition of infant RBC at 4 mo
Visual acuity - 2 and 4 mo
Follow-up:
Anthropometric measures
Blood pressure
Ex vivo cytokine production (e.g. IL-10 and interferon-γ) in whole blood after 24 h of stimulation with bacterial components
Secondary outcomes (12)
Anthropometric measures - 0, 2, 4 and 9 mo
Problem solving at 9 mo
Language development (CDI) at 1 and 2 y
Contrast sensitivity at 2 mo
Vernier acuity at 4 mo
Follow-up:
Heart rate variability
Endothelial function measured by PWV
Plasma IgE
Diet
RBC fatty acid composition
Plasma growth factors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startDec 1998
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Development and HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Research Agency, BASF, Technical University of Denmark
- Investigators
- Lotte Lauritzen, Ph.D, Principal investigator, Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266305
- Sponsor's protocol ID
- KVL-IHE-D72
- Other IDs
- FØTEK 2: 93s-2468-å96-00020, FØTEK 3: 2011-00-0028, KF 01-300/98, KF 01-183/01
- Status last verified
- Aug 2008
- First submitted
- 15 Dec 2005
- Last updated
- 14 Aug 2008
- Results posted
- No
Publications
Lauritzen L, Jorgensen MH, Mikkelsen TB, Skovgaard lM, Straarup EM, Olsen SF, Hoy CE, Michaelsen KF. Maternal fish oil supplementation in lactation: effect on visual acuity and n-3 fatty acid content of infant erythrocytes. Lipids. 2004 Mar;39(3):195-206. doi: 10.1007/s11745-004-1220-8.
PubMed 15233397Lauritzen L, Hoppe C, Straarup EM, Michaelsen KF. Maternal fish oil supplementation in lactation and growth during the first 2.5 years of life. Pediatr Res. 2005 Aug;58(2):235-42. doi: 10.1203/01.PDR.0000169978.92437.58. Epub 2005 Jul 8.
PubMed 16006428Hoppe C, Udam TR, Lauritzen L, Molgaard C, Juul A, Michaelsen KF. Animal protein intake, serum insulin-like growth factor I, and growth in healthy 2.5-y-old Danish children. Am J Clin Nutr. 2004 Aug;80(2):447-52. doi: 10.1093/ajcn/80.2.447.
PubMed 15277169Ulbak J, Lauritzen L, Hansen HS, Michaelsen KF. Diet and blood pressure in 2.5-y-old Danish children. Am J Clin Nutr. 2004 Jun;79(6):1095-102. doi: 10.1093/ajcn/79.6.1095.
PubMed 15159241Lauritzen L, Kjaer TM, Fruekilde MB, Michaelsen KF, Frokiaer H. Fish oil supplementation of lactating mothers affects cytokine production in 2 1/2-year-old children. Lipids. 2005 Jul;40(7):669-76. doi: 10.1007/s11745-005-1429-6.
PubMed 16196417Lauritzen L, Jorgensen MH, Olsen SF, Straarup EM, Michaelsen KF. Maternal fish oil supplementation in lactation: effect on developmental outcome in breast-fed infants. Reprod Nutr Dev. 2005 Sep-Oct;45(5):535-47. doi: 10.1051/rnd:2005044.
PubMed 16188206Larnkjaer A, Christensen JH, Michaelsen KF, Lauritzen L. Maternal fish oil supplementation during lactation does not affect blood pressure, pulse wave velocity, or heart rate variability in 2.5-y-old children. J Nutr. 2006 Jun;136(6):1539-44. doi: 10.1093/jn/136.6.1539.
PubMed 16702318
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil Supplementation in Lactation
- ClinicalTrials.gov ID
- NCT00266305
- Acronym / sponsor ID
- KVL-IHE-D72
- Conditions
- Development and Health
- Keywords
- n-3 LCPUFA, Infant development, Visual acuity, Immune function, Breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Danish Research Agency, BASF, Technical University of Denmark
- Study start
- Dec 1998
- Study completion
- Jan 2007
- First posted
- 16 Dec 2005 (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.
The main purpose of the study was to examine whether fish oil supplementation of lactating mothers affect infant development during first year of life, focusing on visual and mental development. A follow-up studies are conducted in order to see if early intake of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) have any long-term effects on health, primarily immun function and markers of cardiovascular risk.
Detailed description
Background:
Studies indicate that infants, who are fed formula without n-3 LCPUFA, have slower visual development than those, who receive n-3 LCPUFA in breast-milk. The mental development seems also to depend on whether infants are breast-fed or not. Long-term health has also been proposed to be affected (The infant origin of adult disease hypothesis). It is not clear whether these differences is due to dietary LCPUFA as comparison of breast-fed and formula-fed infants are complicated by the socio-demographic differences that exist between mother, who choose to breast-feed or not. Recent studies indicate that LCPUFA supplementation of formulas has beneficial effects on the visual acuity and mental abilities of infants. The LCPUFA content of breast-milk varies and this could potentially be of importance for infant development.
Methods:
211 pregnant women with a high (>80 percentile) or low (< mean) fish intake were recruited. After birth mother with low fish intake were randomized to receive 4 g/day of fish oil or olive oil for the first 4 months of the lactation period. 150 mother-infant pairs were followed for 1 year gathering information on maternal n-3 LCPUFA intake and infant development (growth, developmental milestones, visual acuity, cognitive functions and language acquisition). Milk samples were collected at 0, 2, 4 and 9 months and blood samples were taken from the mother and the infant at 4 months of age in order to determine the biochemical effect of the supplementation.
The children were followed-up at 2½ years of age and around 7 years of age. The study is performed in association to the National Birth Cohort.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Experimental | Behavioral: Fish oil (Dry n-3, BASF) |
| Olive oil | Placebo comparator | Behavioral: Fish oil (Dry n-3, BASF)Control group |
| High fish | No intervention | –Reference group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women with uncomplicated singleton pregnancy
- No metabolic disorders and prepregnancy BMI < 30 kg/m2
- Intention to exclusively breast-feed for 4 mo
- Fish intake below the Danish mean or above 80th percentile (reference group)
Key exclusion criteria (5 listed)
- Pre- or post term delivery (< 37 or > 43 wks of gestation)
- Abnormal weight for gestation (outside 10th-90th percentile range)
- Apgar score 5 min after delivery < 8
- Infant admission to a neonatal department
- If supplementation did not begin within 2 wks after delivery
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 oil (Dry n-3, BASF)5 g/oil daily for the first four month of lactation | Behavioural | Fish oil, Olive oil |
Primary outcome
Breast milk fatty acid composition - 0, 2, 4 and 9 mo
Fatty acid composition of infant RBC at 4 mo
Visual acuity - 2 and 4 mo
Follow-up:
Anthropometric measures
Blood pressure
Ex vivo cytokine production (e.g. IL-10 and interferon-γ) in whole blood after 24 h of stimulation with bacterial components
12 secondary outcomes
Anthropometric measures - 0, 2, 4 and 9 mo
Problem solving at 9 mo
Language development (CDI) at 1 and 2 y
Contrast sensitivity at 2 mo
Vernier acuity at 4 mo
Follow-up:
Heart rate variability
Endothelial function measured by PWV
Plasma IgE
Diet
RBC fatty acid composition
Plasma growth factors
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 14 Aug 2008.
- Results publication: PubMed 15233397Lauritzen L, Jorgensen MH, Mikkelsen TB, Skovgaard lM, Straarup EM, Olsen SF, Hoy CE, Michaelsen KF. Maternal fish oil supplementation in lactation: effect on visual acuity and n-3 fatty acid content of infant erythrocytes. Lipids. 2004 Mar;39(3):195-206. doi: 10.1007/s11745-004-1220-8.
- Results publication: PubMed 16006428Lauritzen L, Hoppe C, Straarup EM, Michaelsen KF. Maternal fish oil supplementation in lactation and growth during the first 2.5 years of life. Pediatr Res. 2005 Aug;58(2):235-42. doi: 10.1203/01.PDR.0000169978.92437.58. Epub 2005 Jul 8.
- Results publication: PubMed 15277169Hoppe C, Udam TR, Lauritzen L, Molgaard C, Juul A, Michaelsen KF. Animal protein intake, serum insulin-like growth factor I, and growth in healthy 2.5-y-old Danish children. Am J Clin Nutr. 2004 Aug;80(2):447-52. doi: 10.1093/ajcn/80.2.447.
- Results publication: PubMed 15159241Ulbak J, Lauritzen L, Hansen HS, Michaelsen KF. Diet and blood pressure in 2.5-y-old Danish children. Am J Clin Nutr. 2004 Jun;79(6):1095-102. doi: 10.1093/ajcn/79.6.1095.
- Results publication: PubMed 16196417Lauritzen L, Kjaer TM, Fruekilde MB, Michaelsen KF, Frokiaer H. Fish oil supplementation of lactating mothers affects cytokine production in 2 1/2-year-old children. Lipids. 2005 Jul;40(7):669-76. doi: 10.1007/s11745-005-1429-6.
- Results publication: PubMed 16188206Lauritzen L, Jorgensen MH, Olsen SF, Straarup EM, Michaelsen KF. Maternal fish oil supplementation in lactation: effect on developmental outcome in breast-fed infants. Reprod Nutr Dev. 2005 Sep-Oct;45(5):535-47. doi: 10.1051/rnd:2005044.
- Results publication: PubMed 16702318Larnkjaer A, Christensen JH, Michaelsen KF, Lauritzen L. Maternal fish oil supplementation during lactation does not affect blood pressure, pulse wave velocity, or heart rate variability in 2.5-y-old children. J Nutr. 2006 Jun;136(6):1539-44. doi: 10.1093/jn/136.6.1539.
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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.
Lotte Lauritzen, Ph.D principal investigator
Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil (Dry n-3, BASF) in people with Development and Health, run by University of Copenhagen at 1 site in Denmark.
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 5 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 14 Aug 2008. 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 Denmark. 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?
Breast milk fatty acid composition - 0, 2, 4 and 9 mo. 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 NCT00266305, which also lists 7 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 14 Aug 2008.