Clinical trial NCT01840384: Efficacy Study of Multiple Micro Nutrients Supplementation
Official title: Longitudinal Study on the Effect of Multiple Micro Nutrients Supplementation on Haemoglobin Level of 8 to 22-month-old Indonesian Children.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia, Iron-deficiency
Keywords: Healthy infants
Anemia, iron-deficiency
Lead sponsor: PT. Sari Husada
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 239
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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

Primary outcomes:
measure: Haemoglobin level
timeFrame: 12 months
Secondary outcomes:
measure: Anemia prevalence
timeFrame: 12 months
measure: Anthropometric
timeFrame: 24 months of age
measure: Micronutrients
timeFrame: 12 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
Study officials:
affiliation: Medical Research Unit, Faculty of Medicine, University of Indonesia
name: Rini Sekartini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: