Vitamins and Minerals for Children With Downs Syndrome | NCT00378456

Studies
Vitamins and Minerals for Children With Downs Syndrome

NCT00378456

Sponsor

Institute of Child Health

Status

Completed

Last Update Posted

Sep 20, 2006Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Trisiomy 21 (Down Syndrome)

Interventions

Antioxidants- (Vitamins A,C,E Selenium and Zinc)
Folinic acid
Vitamins A,C,E Selenium and Zinc and Folinic acid.
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 19, 2006

First Submission Date that Met QC Criteria

Sep 19, 2006

First Posted Date

Sep 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2006

Last Update Posted Date

Sep 20, 2006Estimated

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No life threatening cardiac disease

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

7 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stuart Logan	Peninsular Medical School, Exeter	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Child Health		Birmingham			United Kingdom
Peninsular Medical School

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18296460	Derived	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.
17344250

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D000975	Antioxidants
D015032	Zinc
D002955	Leucovorin

ID	Term
D001685	Biological Factors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Name	Type	Description	Arm Group Labels	Other Names
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