Efficacy Study of Multiple Micro Nutrients Supplementation

Study Overview
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Brief Summary
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This study is initiated to investigate the effect of multi micronutrient supplementation for 12 months on serum haemoglobin level in Indonesian young children.

Official Title
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Longitudinal Study on the Effect of Multiple Micro Nutrients Supplementation on Haemoglobin Level of 8 to 22-month-old Indonesian Children.

Conditions
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Anemia, Iron-deficiency

Intervention / Treatment
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* Dietary Supplement: Multi-micronutrients
* Dietary Supplement: Maltodextrin and Lactose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 10 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-micronutrients<br>Multi-micronutrients | Dietary Supplement: Multi-micronutrients<br> <br> |
| Placebo Comparator: Maltodextrin and Lactose<br>Placebo contained maltodextrin and lactose | Dietary Supplement: Maltodextrin and Lactose<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin level | Change in serum haemoglobin level after 12 months of intervention | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia prevalence | Change in anemia prevalence from baseline to after 12 months of intervention | 12 months | 
| Anthropometric | Change in anthropometric measurements from baseline until 24 months of age | 24 months of age | 
| Micronutrients | Change in selected micronutrients status from baseline to after 12 months of intervention | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy infants, Anemia, iron-deficiency