Trisiomy 21 (Down Syndrome)NCT00378456
Vitamins and Minerals for Children With Downs Syndrome
A study testing Antioxidants- (Vitamins A,C,E Selenium and Zinc), Folinic acid and Vitamins A,C,E Selenium and Zinc and Folinic acid. in people with Trisiomy 21 (Down Syndrome), run by Institute of Child Health at 3 sites in United Kingdom.
Trial summary
The trial aimed to examine the effects of supplementation with antioxidants and folinic acid on the health, growth and psychomotor development of children with Down syndrome. 156 children with Trisomy 21, less than 7 months of age were recruited and randomised into four groups to receive antioxidants, folinic acid, a… Read more about this study
- Who is it for?
- Ages 0 years to 7 months
- Conditions the study is for
- Trisiomy 21 (Down Syndrome)
- What is being tested?
- Antioxidants- (Vitamins A,C,E Selenium and Zinc), Folinic acid and Vitamins A,C,E Selenium and Zinc and Folinic acid.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 3 sitesUnited Kingdom
- Study dates
- Start not givento not given
- 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 0 years to 7 months
- All sexes
- Child
Who may be able to join
- Under 7 months of age
- Trisomy 21
- Live in recruitment Area-i.e. London inside M25, in West Midlands or SW England.
- One parent speaks English
Who cannot join
- No life threatening cardiac disease
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Institute of Child Health
Birmingham
Peninsular Medical School
Exeter
Institute of Child Health, London
London
About this study
The trial aimed to examine the effects of supplementation with antioxidants and folinic acid on the health, growth and psychomotor development of children with Down syndrome. 156 children with Trisomy 21, less than 7 months of age were recruited and randomised into four groups to receive antioxidants, folinic acid, a combination of antioxidants and folinic acid or a placebo. Blinded outcome assessment was carried out 18 months later.Blood and urine samples were also taken around 12 months of age to examine metabolic effects of supplementation.
- Conditions
- Trisiomy 21 (Down Syndrome)
- Being tested
- Antioxidants- (Vitamins A,C,E Selenium and Zinc), Folinic acid, Vitamins A,C,E Selenium and Zinc and Folinic acid., Placebo
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidants- (Vitamins A,C,E Selenium and Zinc)Drug
Folinic acidDrug
Vitamins A,C,E Selenium and Zinc and Folinic acid.Drug
PlaceboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trisiomy 21 (Down Syndrome)Studies 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
- Double blind
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Stuart Logan, Principal investigator, Peninsular Medical School, Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378456
- Sponsor's protocol ID
- 98CH11
- Status last verified
- Sep 2006
- First submitted
- 19 Sep 2006
- Last updated
- 20 Sep 2006
- Results posted
- No
Publications
Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.
PubMed 18296460Ellis J, Logan S, Pumphrey R, Tan HK, Henley W, Edwards V, Moy R, Gilbert R. Inequalities in provision of the Disability Living Allowance for Down syndrome. Arch Dis Child. 2008 Jan;93(1):14-6. doi: 10.1136/adc.2006.112839. Epub 2007 Mar 7.
PubMed 17344250
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamins and Minerals for Children With Downs Syndrome
- ClinicalTrials.gov ID
- NCT00378456
- Acronym / sponsor ID
- 98CH11
- Conditions
- Trisiomy 21 (Down Syndrome)
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- First posted
- 20 Sep 2006 (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 trial aimed to examine the effects of supplementation with antioxidants and folinic acid on the health, growth and psychomotor development of children with Down syndrome. 156 children with Trisomy 21, less than 7 months of age were recruited and randomised into four groups to receive antioxidants, folinic acid, a combination of antioxidants and folinic acid or a placebo. Blinded outcome assessment was carried out 18 months later.Blood and urine samples were also taken around 12 months of age to examine metabolic effects of supplementation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 0 years to 7 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (4 listed)
- Under 7 months of age
- Trisomy 21
- Live in recruitment Area-i.e. London inside M25, in West Midlands or SW England.
- One parent speaks English
Key exclusion criteria (1 listed)
- No life threatening cardiac disease
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 |
|---|---|---|
| Antioxidants- (Vitamins A,C,E Selenium and Zinc) | Drug | – |
| Folinic acid | Drug | – |
| Vitamins A,C,E Selenium and Zinc and Folinic acid. | Drug | – |
| Placebo | Drug | – |
Primary outcome
Not reported in the source record.
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 2006.
- Derived from this study: PubMed 18296460Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.
- Derived from this study: PubMed 17344250Ellis J, Logan S, Pumphrey R, Tan HK, Henley W, Edwards V, Moy R, Gilbert R. Inequalities in provision of the Disability Living Allowance for Down syndrome. Arch Dis Child. 2008 Jan;93(1):14-6. doi: 10.1136/adc.2006.112839. Epub 2007 Mar 7.
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.
Stuart Logan principal investigator
Peninsular Medical School, Exeter
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidants- (Vitamins A,C,E Selenium and Zinc), Folinic acid and Vitamins A,C,E Selenium and Zinc and Folinic acid. in people with Trisiomy 21 (Down Syndrome), run by Institute of Child Health at 3 sites in United Kingdom.
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 1 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 2006. 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 United Kingdom. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00378456, which also lists 2 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 20 Sep 2006.