Anemia, Iron-deficiencyBabytopNCT01840384
Efficacy Study of Multiple Micro Nutrients Supplementation
A study testing Multi-micronutrients and Maltodextrin and Lactose in people with Anemia, Iron-deficiency, run by PT. Sari Husada at 1 site in Indonesia.
Trial summary
This study is initiated to investigate the effect of multi micronutrient supplementation for 12 months on serum haemoglobin level in Indonesian young children. Read more about this study
- Who is it for?
- Ages 8 to 10 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-deficiency
- What is being tested?
- Multi-micronutrients and Maltodextrin and Lactose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteIndonesia
- Study dates
- Jul 2013to Mar 2015
- 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 8 to 10 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy Indonesian infants
- Age 8-10 month at baseline visit
- Willing to take 2 sachets of study product per day
- Planning to reside in the study area during the next 14-16 months
- Written informed consent by parent(s) or legally acceptable representative (in ICF there is statement that both are agree that child participate in the study)
Who cannot join
- Haemoglobin < 8 g/dL at screening visit*.
- Significant congenital abnormality which according to investigator's clinical judgement will interfere the study conduct and assessment
- Any known conditions likely to affect nutrient absorption diagnosed by the child's physician
- Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special formula is required).
- Any other current or previous illnesses/conditions or intervention which according to investigator's clinical judgement could interfere the study conduct and assessment (e.g. chronic illness or physical or mental handicaps)
- Regular use of MMN supplements syrup (every day in > 1 week) within two weeks prior to entry into the study.
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- Not intending to use micronutrient supplements during the study
- Participation in any other studies involving similar investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Premature birth (gestational age <37 weeks)
- Low birth weight (< 2500 g)
- Severely under nutrition indicated by any of the following criteria: severely stunted: HAZ < -3 SD; severely underweight WAZ <-3 SD; wasted: WHZ <-2 SD
- Subject with haemoglobin level (finger prick blood sample) at screening visit between 8-10 g/dL will be given iron syrup supplementation for 1 month. Thereafter, haemoglobin level (whole blood sample) will be checked at baseline visit:
- If Hb > 10 g/dL, subject is eligible for randomisation
- If Hb < 10 g/dL, subject is not eligible for randomisation and will be given iron syrup supplementation for 2 months
Trial locations and contacts
1 site in 1 country.
Tonny Sundjaya, MD contact
Indonesia1 site
Study site
Jakarta
Dian Novita Chandra, MD, MSc
Rini Sekartini, MD, PhD
About this study
Official title: Longitudinal Study on the Effect of Multiple Micro Nutrients Supplementation on Haemoglobin Level of 8 to 22-month-old Indonesian Children.
This study is initiated to investigate the effect of multi micronutrient supplementation for 12 months on serum haemoglobin level in Indonesian young children.
- Conditions
- Anemia, Iron-deficiency
- Being tested
- Multi-micronutrients, Maltodextrin and Lactose
- Keywords
- Healthy infants, Anemia, iron-deficiency
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-micronutrientsDietary supplement
Maltodextrin and LactoseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Multi-micronutrients | Experimental | Multi-micronutrients Receives: Dietary Supplement: Multi-micronutrients |
| Maltodextrin and Lactose | Placebo comparator | Placebo contained maltodextrin and lactose Receives: Dietary Supplement: Maltodextrin and Lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin level
Change in serum haemoglobin level after 12 months of intervention
Measured: 12 months
Secondary outcomes (3)
Anemia prevalence
Change in anemia prevalence from baseline to after 12 months of intervention
Measured: 12 months
Anthropometric
Change in anthropometric measurements from baseline until 24 months of age
Measured: 24 months of age
Micronutrients
Change in selected micronutrients status from baseline to after 12 months of intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron-deficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 239 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT. Sari Husada
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rini Sekartini, MD, PhD, Principal investigator, Medical Research Unit, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840384
- Sponsor's protocol ID
- CT.01.2012
- Acronym
- Babytop
- Status last verified
- Apr 2013
- First submitted
- 23 Apr 2013
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study on the Effect of Multiple Micro Nutrients Supplementation on Haemoglobin Level of 8 to 22-month-old Indonesian Children.
- ClinicalTrials.gov ID
- NCT01840384
- Acronym / sponsor ID
- Babytop / CT.01.2012
- Conditions
- Anemia, Iron-deficiency
- Keywords
- Healthy infants, Anemia, iron-deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 239 participants (estimated)
- Lead sponsor
- PT. Sari HusadaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 25 Apr 2013 (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 study is initiated to investigate the effect of multi micronutrient supplementation for 12 months on serum haemoglobin level in Indonesian young children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-micronutrients | Experimental | Dietary Supplement: Multi-micronutrientsMulti-micronutrients |
| Maltodextrin and Lactose | Placebo comparator | Dietary Supplement: Maltodextrin and LactosePlacebo contained maltodextrin and lactose |
Who may qualify
- Ages
- 8 to 10 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Apparently healthy Indonesian infants
- Age 8-10 month at baseline visit
- Willing to take 2 sachets of study product per day
- Planning to reside in the study area during the next 14-16 months
- Written informed consent by parent(s) or legally acceptable representative (in ICF there is statement that both are agree that child participate in the study)
Key exclusion criteria (14 listed)
- Haemoglobin < 8 g/dL at screening visit*.
- Significant congenital abnormality which according to investigator's clinical judgement will interfere the study conduct and assessment
- Any known conditions likely to affect nutrient absorption diagnosed by the child's physician
- Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special formula is required).
- Any other current or previous illnesses/conditions or intervention which according to investigator's clinical judgement could interfere the study conduct and assessment (e.g. chronic illness or physical or mental handicaps)
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 |
|---|---|---|
| Multi-micronutrients | Dietary supplement | Multi-micronutrients |
| Maltodextrin and Lactose | Dietary supplement | Maltodextrin and Lactose |
Primary outcome
Haemoglobin level
Time frame: 12 months
Change in serum haemoglobin level after 12 months of intervention
3 secondary outcomes
Anemia prevalence
Time frame: 12 months
Anthropometric
Time frame: 24 months of age
Micronutrients
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
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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.
Tonny Sundjaya, MD contact
Rini Sekartini, MD, PhD principal investigator
Medical Research Unit, Faculty of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-micronutrients and Maltodextrin and Lactose in people with Anemia, Iron-deficiency, run by PT. Sari Husada at 1 site in Indonesia.
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 14 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: status not confirmed, as of the sponsor's last update on 25 Apr 2013. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tonny Sundjaya, MD (tonny.sundjaya@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin level (time frame: 12 months). 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 25 Apr 2013.