Rett SyndromeNCT00004656
Nutritional Aspects of Rett Syndrome
A study testing Metabolic assessment with body composition evaluation in people with Rett Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
OBJECTIVES: I. Determine dietary macronutrient intake in children with Rett syndrome and in healthy controls. II. Measure sleeping and awake metabolic rates in various positions, i.e., reclining, sitting, and standing, by whole-room indirect calorimetry and isotope dilution. III. Read more about this study
- Who is it for?
- Ages 5 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rett Syndrome
- What is being tested?
- Metabolic assessment with body composition evaluation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 1993to 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 5 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
PROTOCOL ENTRY CRITERIA:
Patients aged 5 to 18 with Rett syndrome Able to sleep and awaken alone
About this study
OBJECTIVES: I. Determine dietary macronutrient intake in children with Rett syndrome and in healthy controls.
II. Measure sleeping and awake metabolic rates in various positions, i.e., reclining, sitting, and standing, by whole-room indirect calorimetry and isotope dilution.
Read more
III. Quantify activity patterns by time-motion studies using 24-hour activity records and 12-hour videotaping.
IV. Correlate 24-hour activity patterns with 24-hour heart rate telemetry and short-term oxygen consumption.
- Estimate 24-hour fecal and urinary energy losses. VI. Determine body composition by clinical anthropometry, whole-body potassium counting, and total-body electrical conductance.
VII. Calculate apparent energy needs based on measurement of energy intake and expenditure.
Read the detailed description
PROTOCOL OUTLINE:
All participants undergo extensive nutritional and metabolic assessment with body composition evaluation. Studies include macronutrient intake, body fat, lean muscle mass, metabolic rate, and time-action studies; and 24-hour cardiac telemetry. Rett syndrome girls also receive a hemogram and hand x-ray.
- Conditions
- Rett Syndrome
- Being tested
- Metabolic assessment with body composition evaluation
- Keywords
- Rett syndrome, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Rett Syndrome, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic assessment with body composition evaluationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startMay 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rett SyndromeStudies 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
- Diagnosis
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Baylor College of Medicine
- Investigators
- Kathleen J. Motil, Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004656
- Sponsor's protocol ID
- 199/11814
- Other IDs
- BCM-CNRC-H1637
- Status last verified
- Feb 1999
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Aspects of Rett Syndrome
- ClinicalTrials.gov ID
- NCT00004656
- Acronym / sponsor ID
- 199/11814
- Conditions
- Rett Syndrome
- Keywords
- Rett syndrome, neurologic and psychiatric disorders, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Baylor College of Medicine
- Study start
- May 1993
- First posted
- 25 Feb 2000 (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.
OBJECTIVES: I. Determine dietary macronutrient intake in children with Rett syndrome and in healthy controls.
II. Measure sleeping and awake metabolic rates in various positions, i.e., reclining, sitting, and standing, by whole-room indirect calorimetry and isotope dilution.
III. Quantify activity patterns by time-motion studies using 24-hour activity records and 12-hour videotaping.
IV. Correlate 24-hour activity patterns with 24-hour heart rate telemetry and short-term oxygen consumption.
- Estimate 24-hour fecal and urinary energy losses. VI. Determine body composition by clinical anthropometry, whole-body potassium counting, and total-body electrical conductance.
VII. Calculate apparent energy needs based on measurement of energy intake and expenditure.
Detailed description
PROTOCOL OUTLINE:
All participants undergo extensive nutritional and metabolic assessment with body composition evaluation. Studies include macronutrient intake, body fat, lean muscle mass, metabolic rate, and time-action studies; and 24-hour cardiac telemetry. Rett syndrome girls also receive a hemogram and hand x-ray.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 5 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Metabolic assessment with body composition evaluation | Procedure or surgery | – |
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 24 Jun 2005.
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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.
Kathleen J. Motil study chair
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic assessment with body composition evaluation in people with Rett Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jun 2005. 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.
Where can I read the original study information?
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 24 Jun 2005.