Nutritional StatusPhase 1NCT02201225
A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children.
A Phase 1 study testing Nutritional supplement with micronutrient and Nutritional supplement without micronutrient in people with Nutritional Status, run by GlaxoSmithKline at 1 site in India.
Trial summary
This methodology study will evaluate the sensitivity in using sitting knee digital caliper to measure changes in sitting knee length from over a 12-week study period amidst children in the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who are receiving nutritional supplementation with… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Status
- What is being tested?
- Nutritional supplement with micronutrient and Nutritional supplement without micronutrient
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2014to 13 Mar 2015
- Phase
- Phase 1
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children (participants), both boys and girls, aged 6 to 12 years.
- Participant height to be within the 25th to the 75th percentile of the standard height average in Indian children population
- Participant will agree not to take any other nutritional supplements products during the study except the trial supplement
Who cannot join
- Participant has any of the following medical conditions: Genetic disorders, chronic disease, metabolic disorders, endocrine disorders, immobilisation, and miscellaneous
- Participant who in the past 6 months has used dietary or nutritional supplements with micronutrient fortification, or any form of dietary or herbal supplement intended to increase micronutrient intake, at a frequency of greater than 3-4times per month.
- Participant receiving any supplements (such as calcium, iron and/or multivitamin at the time of screening).
- Children (Participant) in Care are not allowed to participate in the study.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Health conditions that would affect food metabolism including the following food allergies, kidney disease, liver disease, and/or gastrointestinal diseases (e.g. irritable bowel syndrome, celiac disease, peptic ulcers).
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- Use of concomitant medications that, in the opinion of the Principal Investigator (PI), might interfere with the outcome of the study or increases the risk of the participant, including corticosteroids (systemic or inhaled) and any medication for any behaviour-related disorders and/or stimulants.
- Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder, including history of alcohol or substance abuse, that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the PI/medical examiner.
- Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Personnel: Currently, the participant's parents/legal guardian is an employee of the Sponsor or the study or members of their immediate family.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children Aged 6 to 12 Years Receiving Nutritional Supplement With or Without Micronutrient Fortification
This methodology study will evaluate the sensitivity in using sitting knee digital caliper to measure changes in sitting knee length from over a 12-week study period amidst children in the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who are receiving nutritional supplementation with micronutrients or without micronutrients.
- Conditions
- Nutritional Status
- Being tested
- Nutritional supplement with micronutrient, Nutritional supplement without micronutrient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplement with micronutrientDietary supplement
Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve
Nutritional supplement without micronutrientDietary supplement
Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplement with micronutrient | Active comparator | Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily Receives: Dietary Supplement: Nutritional supplement with micronutrient |
| Nutritional supplement without micronutrient | Sham comparator | Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily Receives: Dietary Supplement: Nutritional supplement without micronutrient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 12 in bone growth, as measured by sitting knee length caliper.
To evaluate the sensitivity of a sitting knee digital caliper to measure changes in sitting knee length from Baseline to Week 12 in a community-based study in the presence of nutritional supplementation with or without micronutrients.
Measured: Baseline to Week 12
Secondary outcomes (2)
Change from Baseline to Week 12 in Z-score based on the standing height
Comparison of standing height and sitting knee height to asses growth
Measured: Baseline-Week 12
Change from Baseline to Week 8 in bone growth, as measured by sitting knee length digital caliper
To assess the relationship between changes from Baseline to Week 8 in sitting knee length and standing height in the presence of nutritional supplementation with or without micronutrients
Measured: Baseline-Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study start1 Oct 2014
- Primary completion1 Mar 2015
- Study completion13 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201225
- Sponsor's protocol ID
- 201133
- Other IDs
- RH01817
- Status last verified
- Jan 2018
- First submitted
- 24 Jul 2014
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children Aged 6 to 12 Years Receiving Nutritional Supplement With or Without Micronutrient Fortification
- ClinicalTrials.gov ID
- NCT02201225
- Acronym / sponsor ID
- 201133
- Conditions
- Nutritional Status
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- 13 Mar 2015 (actual)
- First posted
- 28 Jul 2014 (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.
This methodology study will evaluate the sensitivity in using sitting knee digital caliper to measure changes in sitting knee length from over a 12-week study period amidst children in the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who are receiving nutritional supplementation with micronutrients or without micronutrients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplement with micronutrient | Active comparator | Dietary Supplement: Nutritional supplement with micronutrientNutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily |
| Nutritional supplement without micronutrient | Sham comparator | Dietary Supplement: Nutritional supplement without micronutrientNutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children (participants), both boys and girls, aged 6 to 12 years.
- Participant height to be within the 25th to the 75th percentile of the standard height average in Indian children population
- Participant will agree not to take any other nutritional supplements products during the study except the trial supplement
Key exclusion criteria (10 listed)
- Participant has any of the following medical conditions: Genetic disorders, chronic disease, metabolic disorders, endocrine disorders, immobilisation, and miscellaneous
- Participant who in the past 6 months has used dietary or nutritional supplements with micronutrient fortification, or any form of dietary or herbal supplement intended to increase micronutrient intake, at a frequency of greater than 3-4times per month.
- Participant receiving any supplements (such as calcium, iron and/or multivitamin at the time of screening).
- Children (Participant) in Care are not allowed to participate in the study.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
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 |
|---|---|---|
| Nutritional supplement with micronutrientNutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve | Dietary supplement | Nutritional supplement with micronutrient |
| Nutritional supplement without micronutrientNutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve | Dietary supplement | Nutritional supplement without micronutrient |
Primary outcome
Change from Baseline to Week 12 in bone growth, as measured by sitting knee length caliper.
Time frame: Baseline to Week 12
To evaluate the sensitivity of a sitting knee digital caliper to measure changes in sitting knee length from Baseline to Week 12 in a community-based study in the presence of nutritional supplementation with or without micronutrients.
2 secondary outcomes
Change from Baseline to Week 12 in Z-score based on the standing height
Time frame: Baseline-Week 12
Change from Baseline to Week 8 in bone growth, as measured by sitting knee length digital caliper
Time frame: Baseline-Week 8
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 12 Jan 2018.
- Results for Study 201133 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nutritional supplement with micronutrient and Nutritional supplement without micronutrient in people with Nutritional Status, run by GlaxoSmithKline at 1 site in India.
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 3 inclusion and 10 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 12 Jan 2018. 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 India. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline to Week 12 in bone growth, as measured by sitting knee length caliper. (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
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 12 Jan 2018.