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Efficacy Study of Multiple Micro Nutrients Supplementation (Babytop)

Primary Purpose

Anemia, Iron-deficiency

Status

Unknown status

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Multi-micronutrients

Maltodextrin and Lactose

About this trial

This is an interventional prevention trial for Anemia, Iron-deficiency focused on measuring Healthy infants, Anemia, iron-deficiency

Eligibility Criteria

8 Months - 10 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Multi-micronutrients

Maltodextrin and Lactose

Arm Description

Multi-micronutrients

Placebo contained maltodextrin and lactose

Outcomes

Primary Outcome Measures

Haemoglobin level

Change in serum haemoglobin level after 12 months of intervention

Secondary Outcome Measures

Anemia prevalence

Change in anemia prevalence from baseline to after 12 months of intervention

Anthropometric

Change in anthropometric measurements from baseline until 24 months of age

Micronutrients

Change in selected micronutrients status from baseline to after 12 months of intervention

Full Information

NCT ID

NCT01840384

First Posted

April 23, 2013

Last Updated

April 23, 2013

Sponsor

PT. Sari Husada

1. Study Identification

Unique Protocol Identification Number

NCT01840384

Brief Title

Efficacy Study of Multiple Micro Nutrients Supplementation

Acronym

Babytop

Official Title

Longitudinal Study on the Effect of Multiple Micro Nutrients Supplementation on Haemoglobin Level of 8 to 22-month-old Indonesian Children.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

March 2015 (Anticipated)

Study Completion Date

March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT. Sari Husada

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Iron-deficiency

Keywords

Healthy infants, Anemia, iron-deficiency

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

239 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multi-micronutrients

Arm Type

Experimental

Arm Description

Multi-micronutrients

Arm Title

Maltodextrin and Lactose

Arm Type

Placebo Comparator

Arm Description

Placebo contained maltodextrin and lactose

Intervention Type

Dietary Supplement

Intervention Name(s)

Multi-micronutrients

Intervention Type

Dietary Supplement

Intervention Name(s)

Maltodextrin and Lactose

Primary Outcome Measure Information:

Title

Haemoglobin level

Description

Change in serum haemoglobin level after 12 months of intervention

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Anemia prevalence

Description

Change in anemia prevalence from baseline to after 12 months of intervention

Time Frame

12 months

Title

Anthropometric

Description

Change in anthropometric measurements from baseline until 24 months of age

Time Frame

24 months of age

Title

Micronutrients

Description

Change in selected micronutrients status from baseline to after 12 months of intervention

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Months

Maximum Age & Unit of Time

10 Months

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tonny Sundjaya, MD

tonny.sundjaya@danone.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rini Sekartini, MD, PhD

Organizational Affiliation

Medical Research Unit, Faculty of Medicine, University of Indonesia

Official's Role

Principal Investigator

Facility Information:

City

Jakarta

Country

Indonesia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dian Novita Chandra, MD, MSc

First Name & Middle Initial & Last Name & Degree

Rini Sekartini, MD, PhD

First Name & Middle Initial & Last Name & Degree

Saptawati Bardosono, MD, MSc, PhD

First Name & Middle Initial & Last Name & Degree

Tjhin Wiguna, MD

First Name & Middle Initial & Last Name & Degree

Dian Novita Chandra, MD, MSc

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Multiple Micro Nutrients Supplementation

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