CClinicalTrials.gg
Status unknownNCT01840384BabytopUpdated Apr 25, 2013

Efficacy Study of Multiple Micro Nutrients Supplementation

An interventional study of Multi-micronutrients and Maltodextrin and Lactose in Anemia, Iron-deficiency, sponsored by PT. Sari Husada. Status unknown at 1 site in Indonesia. Open to participants aged 8 Months to 10 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-25.

Sponsored by PT. Sari Husada · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
239
Allocation
Randomized
Ages
8 Months to 10 Months
Sex
All
01

Study summary

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

02

Conditions studied

  • Anemia, Iron-deficiency

Keywords

  • Healthy infants
  • Anemia, iron-deficiency
03

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's planned enrollment of 239 is above the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

PT. Sari Husada is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Months to 10 Months
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
239 participants (estimated)

Study arms

  • Experimental
    Multi-micronutrients

    Multi-micronutrients

    Dietary Supplement: Multi-micronutrients

  • Placebo comparator
    Maltodextrin and Lactose

    Placebo contained maltodextrin and lactose

    Dietary Supplement: Maltodextrin and Lactose

Interventions

  • Dietary supplementMulti-micronutrients
  • Dietary supplementMaltodextrin and Lactose
06

What researchers measure

Primary outcomes

  1. Haemoglobin level

    Change in serum haemoglobin level after 12 months of intervention

    Time frame: 12 months

Secondary outcomes

  1. Anemia prevalence

    Change in anemia prevalence from baseline to after 12 months of intervention

    Time frame: 12 months

  2. Anthropometric

    Change in anthropometric measurements from baseline until 24 months of age

    Time frame: 24 months of age

  3. Micronutrients

    Change in selected micronutrients status from baseline to after 12 months of intervention

    Time frame: 12 months

07

Study locations

1 site
  • Jakarta, Indonesia
    • Dian Novita Chandra, MD, MSc · Contact
    • Rini Sekartini, MD, PhD · Principal investigator
    • Saptawati Bardosono, MD, MSc, PhD · Sub investigator
    • Tjhin Wiguna, MD · Sub investigator
    • Dian Novita Chandra, MD, MSc · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01840384
Lead sponsor
PT. Sari Husada
Responsible party
Sponsor
First posted
Apr 25, 2013
Start date
Jul 2013
Primary completion
Mar 2015 (estimated)
Completion
Mar 2015 (estimated)
Last update
Apr 25, 2013

Study contacts

Tonny Sundjaya, MD
Contact
tonny.sundjaya@danone.com
Rini Sekartini, MD, PhD
principal investigator · Medical Research Unit, Faculty of Medicine, University of Indonesia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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