Anemia, Iron-deficiency
Conditions
Keywords
Healthy infants, Anemia, iron-deficiency
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.
Interventions
DIETARY_SUPPLEMENTMulti-micronutrients
DIETARY_SUPPLEMENTMaltodextrin and Lactose
Sponsors
PT. Sari Husada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Months to 10 Months
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemoglobin level | 12 months | Change in serum haemoglobin level after 12 months of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anemia prevalence | 12 months | Change in anemia prevalence from baseline to after 12 months of intervention |
| Anthropometric | 24 months of age | Change in anthropometric measurements from baseline until 24 months of age |
| Micronutrients | 12 months | Change in selected micronutrients status from baseline to after 12 months of intervention |
Countries
Indonesia
Contacts
Primary ContactTonny Sundjaya, MD
Outcome results
None listed