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Efficacy Study of Multiple Micro Nutrients Supplementation (Babytop)

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ClinicalTrials.gov Identifier: NCT01840384
Recruitment Status : Unknown
Verified April 2013 by PT. Sari Husada.
Recruitment status was:  Not yet recruiting
First Posted : April 25, 2013
Last Update Posted : April 25, 2013
Sponsor:
Information provided by (Responsible Party):
PT. Sari Husada

April 23, 2013
April 25, 2013
April 25, 2013
July 2013
March 2015   (Final data collection date for primary outcome measure)
Haemoglobin level [ Time Frame: 12 months ]
Change in serum haemoglobin level after 12 months of intervention
Same as current
No Changes Posted
  • Anemia prevalence [ Time Frame: 12 months ]
    Change in anemia prevalence from baseline to after 12 months of intervention
  • Anthropometric [ Time Frame: 24 months of age ]
    Change in anthropometric measurements from baseline until 24 months of age
  • Micronutrients [ Time Frame: 12 months ]
    Change in selected micronutrients status from baseline to after 12 months of intervention
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Anemia, Iron-deficiency
  • Dietary Supplement: Multi-micronutrients
  • Dietary Supplement: Maltodextrin and Lactose
  • Experimental: Multi-micronutrients
    Multi-micronutrients
    Intervention: Dietary Supplement: Multi-micronutrients
  • Placebo Comparator: Maltodextrin and Lactose
    Placebo contained maltodextrin and lactose
    Intervention: Dietary Supplement: Maltodextrin and Lactose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
239
Same as current
March 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Months to 10 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
 
NCT01840384
CT.01.2012
No
Not Provided
Not Provided
PT. Sari Husada
PT. Sari Husada
Not Provided
Principal Investigator: Rini Sekartini, MD, PhD Medical Research Unit, Faculty of Medicine, University of Indonesia
PT. Sari Husada
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP