Efficacy Study of Multiple Micro Nutrients Supplementation (Babytop)

Sarihusada

Status: Unknown

Conditions: Anemia, Iron-deficiency

Treatments: Dietary Supplement: Maltodextrin and Lactose; Dietary Supplement: Multi-micronutrients

Study type: Interventional

Funder types: Industry

Identifiers

NCT01840384

CT.01.2012

Details and patient eligibility

About

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

Enrollment: 239 estimated patients

Sex: All

Ages: 8 to 10 months old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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239 participants in 2 patient groups, including a placebo group

Multi-micronutrients

Experimental group

Description:

Multi-micronutrients

Treatment:

Dietary Supplement: Multi-micronutrients

Maltodextrin and Lactose

Placebo Comparator group

Description:

Placebo contained maltodextrin and lactose

Treatment:

Dietary Supplement: Maltodextrin and Lactose