Efficacy Study of Multiple Micro Nutrients Supplementation (Babytop)

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.

Study Overview

• Status: Unknown
• Conditions: Anemia, Iron-deficiency
• Intervention / Treatment: Dietary supplement: Multi-micronutrients; Dietary supplement: Maltodextrin and Lactose

• Study Type: Interventional
• Enrollment (Anticipated): 239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 10 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Multi-micronutrients	Dietary supplement: Multi-micronutrients
PLACEBO_COMPARATOR: Maltodextrin and Lactose; Placebo contained maltodextrin and lactose	Dietary supplement: Maltodextrin and Lactose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin level	Change in serum haemoglobin level after 12 months of intervention	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anemia prevalence	Change in anemia prevalence from baseline to after 12 months of intervention	12 months
Anthropometric	Change in anthropometric measurements from baseline until 24 months of age	24 months of age
Micronutrients	Change in selected micronutrients status from baseline to after 12 months of intervention	12 months

Collaborators and Investigators

• Sponsor: PT. Sari Husada
• Investigators: Principal Investigator: Rini Sekartini, MD, PhD, Medical Research Unit, Faculty of Medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ANTICIPATED): March 1, 2015
• Study Completion (ANTICIPATED): March 1, 2015

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (ESTIMATE): April 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 25, 2013
• Last Update Submitted That Met QC Criteria: April 23, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Healthy infants; Anemia, iron-deficiency
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: CT.01.2012