Status:
UNKNOWN
Efficacy Study of Multiple Micro Nutrients Supplementation
Lead Sponsor:
PT. Sari Husada
Conditions:
Anemia, Iron-deficiency
Eligibility:
All Genders
8-10 years
Phase:
NA
Brief Summary
This study is initiated to investigate the effect of multi micronutrient supplementation for 12 months on serum haemoglobin level in Indonesian young children.
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT01840384
Start Date
July 1 2013
End Date
March 1 2015
Last Update
April 25 2013
Active Locations (1)
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1
Jakarta, Indonesia