Efficacy Study of Multiple Micro Nutrients Supplementation

Anemia, Iron-deficiency Clinical Trial

— Babytop  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01840384
• Other study ID #: CT.01.2012
• 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

• Anemia, Iron-deficiency

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