Efficacy Study of Multiple Micro Nutrients Supplementation (Babytop)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by PT. Sari Husada
Sponsor:
Information provided by (Responsible Party):
PT. Sari Husada
ClinicalTrials.gov Identifier:
NCT01840384
First received: April 23, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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


Condition Intervention
Anemia, Iron-deficiency
Dietary Supplement: Multi-micronutrients
Dietary Supplement: Maltodextrin and Lactose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by PT. Sari Husada:

Primary Outcome Measures:
  • Haemoglobin level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in serum haemoglobin level after 12 months of intervention


Secondary Outcome Measures:
  • Anemia prevalence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in anemia prevalence from baseline to after 12 months of intervention

  • Anthropometric [ Time Frame: 24 months of age ] [ Designated as safety issue: Yes ]
    Change in anthropometric measurements from baseline until 24 months of age

  • Micronutrients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in selected micronutrients status from baseline to after 12 months of intervention


Estimated Enrollment: 239
Study Start Date: July 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multi-micronutrients
Multi-micronutrients
Dietary Supplement: Multi-micronutrients
Placebo Comparator: Maltodextrin and Lactose
Placebo contained maltodextrin and lactose
Dietary Supplement: Maltodextrin and Lactose

  Eligibility

Ages Eligible for Study:   8 Months to 10 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: PT. Sari Husada
ClinicalTrials.gov Identifier: NCT01840384     History of Changes
Other Study ID Numbers: CT.01.2012
Study First Received: April 23, 2013
Last Updated: April 23, 2013
Health Authority: Indonesia: National Agency of Drug and Food Control

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

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

ClinicalTrials.gov processed this record on July 29, 2014