HealthyNCT00610922
Docosaexahenoic Acid and Gross Motor Milestones in Infants
A study testing Docosahexaenoic acid (DHA) in people with Healthy, run by University of Milan.
Trial summary
To examine whether daily supplement of docosahexaenoic acid throughout the first year of life may speed up the achievement of gross motor development milestones in healthy infants, a total of 1160 healthy infants randomly allocated to receive throughout the first year of life daily oral supplement of vitamin D3 (400… Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Healthy
- What is being tested?
- Docosahexaenoic acid (DHA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,160 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Dec 2006
- 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 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- weight at birth equal or above 2500 g;
- gestational age between 37 and 42 completed weeks;
- single birth;
- absence of neonatal or birth abnormalities;
- Apgar score greater than or equal to 7 at 5 m;
- white parents.
Who cannot join
- presence of neonatal diseases requiring hospitalisation for longer than 7 days;
- unknown father;
- parents unable to understand the protocol requirements and to fill out the infants diary;
- infant already enrolled or selected for another clinical study.
About this study
Official title: RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.
To examine whether daily supplement of docosahexaenoic acid throughout the first year of life may speed up the achievement of gross motor development milestones in healthy infants, a total of 1160 healthy infants randomly allocated to receive throughout the first year of life daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3 (400 IU) alone. Primary outcome measure: time of achieving gross motor development milestones. Secondary outcome measure: time of achieving early fine motor development milestones and language.
- Conditions
- Healthy
- Being tested
- Docosahexaenoic acid (DHA)
- Keywords
- Performance of motor skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acid (DHA)Dietary supplement
DHA 20 mg per day through 12 months of life
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | Not described Receives: Dietary Supplement: Docosahexaenoic acid (DHA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of achieving the four gross motor development milestones
Measured: 4, 8 and 12 months of age
Secondary outcomes (1)
time of achieving early fine motor milestones and language
Measured: 4, 8 and 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startMay 2005
- Primary completionDec 2006
- Study completionDec 2006
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 HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Investigators
- Carlo Agostoni, Prof, Principal investigator, Dept. of Pediatrics, San Paolo Hospital, University of MIlan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610922
- Sponsor's protocol ID
- NEON-02/2005-DHA
- Status last verified
- Jan 2008
- First submitted
- 28 Jan 2008
- Last updated
- 8 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Agostoni C, Zuccotti GV, Radaelli G, Besana R, Podesta A, Sterpa A, Rottoli A, Riva E, Giovannini M. Docosahexaenoic acid supplementation and time at achievement of gross motor milestones in healthy infants: a randomized, prospective, double-blind, placebo-controlled trial. Am J Clin Nutr. 2009 Jan;89(1):64-70. doi: 10.3945/ajcn.2008.26590. Epub 2008 Dec 3.
PubMed 19056592
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.
- ClinicalTrials.gov ID
- NCT00610922
- Acronym / sponsor ID
- NEON-02/2005-DHA
- Conditions
- Healthy
- Keywords
- Performance of motor skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,160 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 8 Feb 2008 (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.
To examine whether daily supplement of docosahexaenoic acid throughout the first year of life may speed up the achievement of gross motor development milestones in healthy infants, a total of 1160 healthy infants randomly allocated to receive throughout the first year of life daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3 (400 IU) alone. Primary outcome measure: time of achieving gross motor development milestones. Secondary outcome measure: time of achieving early fine motor development milestones and language.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Dietary Supplement: Docosahexaenoic acid (DHA) |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- weight at birth equal or above 2500 g;
- gestational age between 37 and 42 completed weeks;
- single birth;
- absence of neonatal or birth abnormalities;
- Apgar score greater than or equal to 7 at 5 m;
Key exclusion criteria (4 listed)
- presence of neonatal diseases requiring hospitalisation for longer than 7 days;
- unknown father;
- parents unable to understand the protocol requirements and to fill out the infants diary;
- infant already enrolled or selected for another clinical study.
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 |
|---|---|---|
| Docosahexaenoic acid (DHA)DHA 20 mg per day through 12 months of life | Dietary supplement | 2 |
Primary outcome
time of achieving the four gross motor development milestones
Time frame: 4, 8 and 12 months of age
1 secondary outcome
time of achieving early fine motor milestones and language
Time frame: 4, 8 and 12 months of age
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 8 Feb 2008.
- Derived from this study: PubMed 19056592Agostoni C, Zuccotti GV, Radaelli G, Besana R, Podesta A, Sterpa A, Rottoli A, Riva E, Giovannini M. Docosahexaenoic acid supplementation and time at achievement of gross motor milestones in healthy infants: a randomized, prospective, double-blind, placebo-controlled trial. Am J Clin Nutr. 2009 Jan;89(1):64-70. doi: 10.3945/ajcn.2008.26590. Epub 2008 Dec 3.
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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.
Carlo Agostoni, Prof principal investigator
Dept. of Pediatrics, San Paolo Hospital, University of MIlan, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Docosahexaenoic acid (DHA) in people with Healthy, run by University of Milan.
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 6 inclusion and 4 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 8 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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 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?
time of achieving the four gross motor development milestones (time frame: 4, 8 and 12 months of age). 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 NCT00610922, 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 8 Feb 2008.