Efficacy Study of Multiple Micro Nutrients Supplementation

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.

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