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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01840384
Other study ID # CT.01.2012
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 23, 2013
Last updated April 23, 2013
Start date July 2013
Est. completion date March 2015

Study information

Verified date April 2013
Source PT. Sari Husada
Contact Tonny Sundjaya, MD
Email tonny.sundjaya@danone.com
Is FDA regulated No
Health authority Indonesia: National Agency of Drug and Food Control
Study type Interventional

Clinical Trial Summary

This study is initiated to investigate the effect of multi micronutrient supplementation for 12 months on serum haemoglobin level in Indonesian young children.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 239
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Months to 10 Months
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Multi-micronutrients

Maltodextrin and Lactose


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
PT. Sari Husada

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Haemoglobin level Change in serum haemoglobin level after 12 months of intervention 12 months No
Secondary Anemia prevalence Change in anemia prevalence from baseline to after 12 months of intervention 12 months No
Secondary Anthropometric Change in anthropometric measurements from baseline until 24 months of age 24 months of age Yes
Secondary Micronutrients Change in selected micronutrients status from baseline to after 12 months of intervention 12 months No
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