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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

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.

Condition or disease Intervention/treatment Phase
Anemia, Iron-deficiency Dietary Supplement: Multi-micronutrients Dietary Supplement: Maltodextrin and Lactose Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Longitudinal Study on the Effect of Multiple Micro Nutrients Supplementation on Haemoglobin Level of 8 to 22-month-old Indonesian Children.
Study Start Date : July 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multi-micronutrients
Multi-micronutrients
Dietary Supplement: Multi-micronutrients
Placebo Comparator: Maltodextrin and Lactose
Placebo contained maltodextrin and lactose
Dietary Supplement: Maltodextrin and Lactose



Primary Outcome Measures :
  1. Haemoglobin level [ Time Frame: 12 months ]
    Change in serum haemoglobin level after 12 months of intervention


Secondary Outcome Measures :
  1. Anemia prevalence [ Time Frame: 12 months ]
    Change in anemia prevalence from baseline to after 12 months of intervention

  2. Anthropometric [ Time Frame: 24 months of age ]
    Change in anthropometric measurements from baseline until 24 months of age

  3. Micronutrients [ Time Frame: 12 months ]
    Change in selected micronutrients status from baseline to after 12 months of intervention



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Ages Eligible for Study:   8 Months to 10 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840384


Contacts
Contact: Tonny Sundjaya, MD tonny.sundjaya@danone.com

Locations
Indonesia
Not yet recruiting
Jakarta, Indonesia
Contact: Dian Novita Chandra, MD, MSc         
Principal Investigator: Rini Sekartini, MD, PhD         
Sub-Investigator: Saptawati Bardosono, MD, MSc, PhD         
Sub-Investigator: Tjhin Wiguna, MD         
Sub-Investigator: Dian Novita Chandra, MD, MSc         
Sponsors and Collaborators
PT. Sari Husada
Investigators
Principal Investigator: Rini Sekartini, MD, PhD Medical Research Unit, Faculty of Medicine, University of Indonesia

Responsible Party: PT. Sari Husada
ClinicalTrials.gov Identifier: NCT01840384     History of Changes
Other Study ID Numbers: CT.01.2012
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: April 25, 2013
Last Verified: April 2013

Keywords provided by PT. Sari Husada:
Healthy infants
Anemia, iron-deficiency

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs