Efficacy Study of Multiple Micro Nutrients Supplementation

NCT ID: NCT01840384

Last Updated: 2013-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-03-31

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.

Conditions

Anemia, Iron-deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Multi-micronutrients

Multi-micronutrients

Group Type: EXPERIMENTAL

Multi-micronutrients

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin and Lactose

Placebo contained maltodextrin and lactose

Group Type: PLACEBO_COMPARATOR

Maltodextrin and Lactose

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Multi-micronutrients

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin and Lactose

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 8 Months
• Maximum Eligible Age: 10 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PT. Sari Husada

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rini Sekartini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Research Unit, Faculty of Medicine, University of Indonesia

Locations

Jakarta, , Indonesia

Countries

Indonesia

Central Contacts

Tonny Sundjaya, MD

Role: CONTACT

tonny.sundjaya@danone.com

Facility Contacts

Dian Novita Chandra, MD, MSc

Role: primary

Other Identifiers

CT.01.2012

Identifier Type: -

Identifier Source: org_study_id