NCT01840384

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 25, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

April 23, 2013

Last Update Submit

April 23, 2013

Conditions

Anemia, Iron-deficiency

Keywords

Healthy infantsAnemia, iron-deficiency

Outcome Measures

Primary Outcomes (1)

  • Haemoglobin level

    Change in serum haemoglobin level after 12 months of intervention

    12 months

Secondary Outcomes (3)

  • Anemia prevalence

    12 months

  • Anthropometric

    24 months of age

  • Micronutrients

    12 months

Study Arms (2)

Multi-micronutrients

EXPERIMENTAL

Multi-micronutrients

Dietary Supplement: Multi-micronutrients

Maltodextrin and Lactose

PLACEBO COMPARATOR

Placebo contained maltodextrin and lactose

Dietary Supplement: Maltodextrin and Lactose

Interventions

Multi-micronutrientsDIETARY_SUPPLEMENT
Multi-micronutrients
Maltodextrin and LactoseDIETARY_SUPPLEMENT
Maltodextrin and Lactose

Eligibility Criteria

Age8 Months - 10 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

maltodextrinLactose

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Rini Sekartini, MD, PhD

    Medical Research Unit, Faculty of Medicine, University of Indonesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tonny Sundjaya, MD

CONTACT

tonny.sundjaya@danone.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 25, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 25, 2013

Record last verified: 2013-04

Locations

ID(1)