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Effect of Double Fortification (Iron and Zinc) in Synbiotic Milk to Under 5 Years Stunted Children Growth

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ClinicalTrials.gov Identifier: NCT03495401
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
DR.Siti Helmyati, DCN, M.Kes, Gadjah Mada University

Brief Summary:
The purpose of this study is to investigate the effects of double fortification (iron and zinc) in synbiotic milk (L.plantarum Dad13 and fructooligosaccharides) on under 5 years stunted children growth, gut microbiota composition, blood zinc and hemoglobin level, and cognitive level.

Condition or disease Intervention/treatment Phase
Stunting Dietary Supplement: fortified synbiotic milk Dietary Supplement: non-fortified synbiotic milk Not Applicable

Detailed Description:
This is a parallel, quadruple-blind, randomized controlled trial to determine the effects of double fortification (iron and zinc) in synbiotic milk (containing 7 billion CFU L.plantarum Dad13 and 4 g fructooligosaccharides) on the gut microbiota composition, body height and weight, blood zinc and hemoglobin level, and cognitive level in under 5 years stunted children subjects. The duration of the study is 4 months, including a 2-week pre test and informed consent before randomization of subjects into treatment or control group, a 12-week intervention period, and a 2-week post test after the end of intervention. During the intervention period, subjects will be instructed to take 100 ml of fortified synbiotic milk or non-fortified synbiotic milk per day. They will also be asked to document consumed milk, any unusual symptoms or side effects of treatment. Diet will be monitored via 24-h dietary recalls and SQ-FFQ before and after treatment respectively. Changes in the gut microbiota composition will be determined by measuring bacterial population levels (Bifidobacteria, Lactobacillus, Enterobacteria, Prevotella, and Bacteroides) in stool sampled collected at baseline and 12 weeks by qPCR. Metabolic markers (calprotectin, hemoglobin, and zinc level) will be measured at baseline and 12-weeks in serum and plasma using biochemical and immuno-assay. Changes in the cognitive level, height for age Z-score collected at baseline and 12 weeks using Bayley Scales of Infant Development, 2nd Edition .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group given fortified synbiotic milk, control group given non-fortified synbiotic milk
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Double Fortification (Iron and Zinc) in Synbiotic Milk to Under 5 Years Stunted Children Growth : the Efforts to Achieve Target 2 SDGs Utilizing Local Natural Resources
Actual Study Start Date : April 28, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: fortified synbiotic milk
100 ml fortified (7,47 mg ferrous sulphate and 4,33 mg zinc acetate) synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
Dietary Supplement: fortified synbiotic milk
100 ml fortified (7,47 mg ferrous sulphate and 4,33 mg zinc acetate) synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
Other Name: susu synbio (synbio milk) fortified

Placebo Comparator: non-fortified synbiotic milk
100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
Dietary Supplement: non-fortified synbiotic milk
100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
Other Name: susu synbio (synbio milk) non-fortified




Primary Outcome Measures :
  1. Changes in Gut Microbiota Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
    Stools samples will be collected and analyzed before and after the intervention and compared between groups (Lactobacillus, Bifidobacteria, Bacteroides, Prevotella, and Enterobacteria) using qPCR method.


Secondary Outcome Measures :
  1. Changes in Height per Age Z-score Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
    Height data will be collected and analyzed before and after the intervention and compared between groups

  2. Changes in Hemoglobin Level Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
    Hemoglobin data will be collected and analyzed before and after the intervention and compared between groups using biochemistry method

  3. Changes in Calprotectin Level Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
    Calprotectin data will be collected and analyzed before and after the intervention and compared between groups using immuno-assay method

  4. Changes in Blood Zinc Level Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
    Calprotectin data will be collected and analyzed before and after the intervention and compared between groups using Atomic Absorbance Spectrophotometry method

  5. Changes in Cognitive Level Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
    Cognitive level will be collected and analyzed before and after the intervention and compared between groups using Bayley Scales of Infant Development, 2nd Edition (BSID). This part of BSID evaluation, which yields a score called the mental development index, evaluates several types of abilities: sensory/perceptual acuities, discriminations, and response; acquisition of object constancy; memory learning and problem solving; vocalization and beginning of verbal communication; basis of abstract thinking; habituation; mental mapping; complex language; and mathematical concept formation. Total score from test will determine mental development index of children : accelerated performance (score ≥85), within normal limit (score 70-84), mildly delayed performance (score 55-69), and significantly delayed performance (score <55).

  6. Changes in Psychomotor Level Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
    Psychomotor data will be collected and analyzed before and after the intervention and compared between groups using Bayley Scales of Infant Development, 2nd Edition (BSID). This part of the BSID assesses the degree of body control, large muscle coordination, finer manipulatory skills of the hands and fingers, dynamic movement, postural imitation, and the ability to recognize objects by sense of touch (stereognosis). Total score from test will determine motor development index of children : accelerated performance (score ≥85), within normal limit (score 70-84), mildly delayed performance (score 55-69), and significantly delayed performance (score <55).



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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age between 2 year to 5 years
  • height per age z-score under -2 (stunting)
  • parents sign inform consent form

Exclusion Criteria:

  • have congenital abnormality
  • lactose intolerant
  • use antibiotic for more than 2 weeks
  • consume micronutrient supplement (especially iron and zinc) in the last 3 months
  • diagnose with chronic diseases and infection that interfere metabolism (i.e. tuberculosis, HIV, autoimmune disease, diabetes mellitus type 1)
  • suffer marasmus and/or kwashiorkor
  • not willing to continue the intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495401


Contacts
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Contact: Siti Helmyati, DR. +62274547775 siti.helmyati@gmail.com
Contact: Lily A. Lestari, DR. +62274547775 santi_wap@yahoo.com

Locations
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Indonesia
Universitas Gadjah Mada Recruiting
Sleman, D.I.Yogyakarta, Indonesia, 55281
Contact: Siti Helmyati, DR.         
Sponsors and Collaborators
Gadjah Mada University
Investigators
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Principal Investigator: Siti Helmyati, DR. Gadjah Mada University
Principal Investigator: Lily A. Lestari, DR. Gadjah Mada University

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Responsible Party: DR.Siti Helmyati, DCN, M.Kes, DR., Gadjah Mada University
ClinicalTrials.gov Identifier: NCT03495401     History of Changes
Other Study ID Numbers: KE/FK/0640/EC/2017
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No