Growth and DevelopmentNCT02254460
Investigation of Iron Uptake From Micronutrient Fortified Powder Versus From Tailored Control in Milk
A study testing Test in people with Growth and Development, run by GlaxoSmithKline at 1 site in India.
Trial summary
The present study supplements iron as part of multiple micro-nutrient supplementation to demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake of key micronutrients like iron due to unique nature of the given matrix, as compared to intake of iron alone in milk. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth and Development
- What is being tested?
- Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- 6 Feb 2013to 8 Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Demonstrates understanding of the study and willingness to participate as evidenced by participants' parents and/or legal guardian's voluntary written informed consent as well as written assent by the participant and has received a signed and dated copy of the informed consent form as well as the assent form
- Participant belonging to middle socio-economic background as per modified Kuppuswamy scale
- Good general and mental health with, in the opinion of the investigator or medically qualified designee
- Child residing in the peri-urban areas of Bangalore city
- Child with Z-scores of: a. height for age of 0 to ≥-3; b. BMI for age of 0 to ≥-3.
Who cannot join
- Children in Care (CiC)
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
- Participants with severe anaemia (Haemoglobin < 8g %) as determined by laboratory results
- Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder 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 investigator
- Recent history (3 months) of serious infections, injuries and/ or surgeries
- Children consuming iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week) in last 6 months prior to screening visit
- Use of any prescription medications within 15 days prior to screening and throughout the entire duration of the study
- Recent history (within the last 1 year) of alcohol or other substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Two-way Cross-over Study to Investigate the Uptake of Iron From Micronutrient Fortified Powder vs. From Tailored Control in Milk.
The present study supplements iron as part of multiple micro-nutrient supplementation to demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake of key micronutrients like iron due to unique nature of the given matrix, as compared to intake of iron alone in milk.
- Conditions
- Growth and Development
- Being tested
- Test, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestDietary supplement
Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.
ControlOther
Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve. Receives: Dietary Supplement: Test |
| Control | Placebo comparator | Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Iron Absorption
Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study start6 Feb 2013
- Primary completion1 Mar 2013
- Study completion8 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Growth and DevelopmentStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 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
- NCT02254460
- Sponsor's protocol ID
- 202738
- Other IDs
- RH01592
- Status last verified
- Jun 2017
- First submitted
- 29 Sep 2014
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Two-way Cross-over Study to Investigate the Uptake of Iron From Micronutrient Fortified Powder vs. From Tailored Control in Milk.
- ClinicalTrials.gov ID
- NCT02254460
- Acronym / sponsor ID
- 202738
- Conditions
- Growth and Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2013
- Primary completion
- 1 Mar 2013 (actual)
- Study completion
- 8 Mar 2013 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Posted 16 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study supplements iron as part of multiple micro-nutrient supplementation to demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake of key micronutrients like iron due to unique nature of the given matrix, as compared to intake of iron alone in milk.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Dietary Supplement: TestExperimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve. |
| Control | Placebo comparator | Other: ControlEnergy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Demonstrates understanding of the study and willingness to participate as evidenced by participants' parents and/or legal guardian's voluntary written informed consent as well as written assent by the participant and has received a signed and dated copy of the informed consent form as well as the assent form
- Participant belonging to middle socio-economic background as per modified Kuppuswamy scale
- Good general and mental health with, in the opinion of the investigator or medically qualified designee
- Child residing in the peri-urban areas of Bangalore city
- Child with Z-scores of: a. height for age of 0 to ≥-3; b. BMI for age of 0 to ≥-3.
Key exclusion criteria (8 listed)
- Children in Care (CiC)
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
- Participants with severe anaemia (Haemoglobin < 8g %) as determined by laboratory results
- Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder 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 investigator
- Recent history (3 months) of serious infections, injuries and/ or surgeries
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 |
|---|---|---|
| TestExperimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve. | Dietary supplement | Test |
| ControlEnergy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve | Other | Control |
Primary outcome
Fractional Iron Absorption
Time frame: Day 15
Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 study testing Test in people with Growth and Development, 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 5 inclusion and 8 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 11 Jul 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fractional Iron Absorption (time frame: Day 15). 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 11 Jul 2017.