Efficacy Study of Multiple Micro Nutrients Supplementation

Not Applicable

• Conditions: Anemia, Iron-deficiency
• Interventions: Dietary Supplement: Multi-micronutrients; Dietary Supplement: Maltodextrin and Lactose

• Registration Number: NCT01840384
• Lead Sponsor: PT. Sari Husada

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-23
• Last Update Submitted: 2013-04-23
• Study First Posted: 2013-04-25
• Last Update Posted: 2013-04-25
• Study Start: 2013-07
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-micronutrients	Multi-micronutrients	Multi-micronutrients
Maltodextrin and Lactose	Maltodextrin and Lactose	Placebo contained maltodextrin and lactose

Primary Outcome Measures

Name	Time	Method
Haemoglobin level	12 months	Change in serum haemoglobin level after 12 months of intervention

Secondary Outcome Measures

Name	Time	Method
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