Trial record 6 of 1231 for:    Open Studies | micronutrients

Efficacy Study of Multiple Micro Nutrients Supplementation (Babytop)

This study is not yet open for participant recruitment.
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
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:
Micronutrients
Trace Elements
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014