NCT04508283

Brief Summary

Fiber as part of the plants can be provided through eating grains, fruits and vegetables. As source of fiber, exclusively breastfed infants do not need additional dietary fiber because breast-milk provides oligosaccharides to maintain the bulk for normal gastrointestinal movements together with gut probiotics. However, after the period of six months of exclusive breastfeeding, then complementary foods are the initial sources of fiber of children aged 6-59 months diet, e.g. cereals, fruits and legumes should then be introduced. However, investigators should consider on the effect of plant foods as a non-haem iron food source that is less bioavailable for iron absorption. There are other dietary factors that inhibit iron bioavailability, i.e. phytates in grains and rice, vegetables protein, calcium and phosphorus in cow's milk and cheese. iron deficiency is remained common globally, especially for children age 6-24 month in which it can developing into a severe condition, i.e. iron deficiency anemia. Iron deficiency as well as anemia is closely related to delay child growth and development, negatively associated with height-for-age, and anemia are at risk for poorer cognitive, motor, social-emotional, and neurophysiologic development in the short- and long-term outcome. The aim of this study is to see the association between fiber intake from different type of milk consumption sources and dietary habits to gastrointestinal health, anemia and growth status among children aged 6-36 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

August 4, 2020

Last Update Submit

September 26, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Fibre intake profile

    Interview the parents about child's food intake using 24-hour food recall and semi-quantitative food frequency questionnaire

    1 day

  • Type of milk consumption

    Interview the parents about child's milk consumption

    1 day

  • Gastrointestinal symptoms

    Interview the parents about child's gastrointestinal symptoms during the past two weeks using VAS on frequency of bowel movements in a week, the presence of difficulty when passing a bowel movement, bloating, abdominal pain/colic, and flatulence, into four scale, i.e. 0 = never, 1 = rarely, 2 = frequently, or 3 = all the time

    1day

  • Iron status

    Child's blood will be taken for hemoglobin assessment

    1 day

  • Nutritional status

    Nutritional status will be determined using weight-for-age, height-for-age and weight-for-height indicator

    1 day

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 6-36 months are recruited from selected Puskesmas (Health Care Center) in Jakarta and Bandung

You may qualify if:

  • Children aged 6-36 months who are recruited from selected Puskesmas (Health Care Center) in Jakarta and Bandung after provided with informed consent from their parents

You may not qualify if:

  • Children who are seriously ill and/or need special medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puskesmas Kecamatan Kampung Melayu

Jakarta, DKI Jakarta, 13320, Indonesia

Location

Related Publications (8)

  • Hermina and Prihartini. Fruits and vegetables consumption of Indonesian population in the context of balanced nutrition: A Further Analysis of Individual Food Consumption Survey (SKMl). Buletin Penelitian Kesehatan (Health Research Bulletin);2016;44(3): 205-218.

    BACKGROUND
  • Rakotonirainy NH, Razafindratovo V, Remonja CR, Rasoloarijaona R, Piola P, Raharintsoa C, Randremanana RV. Dietary diversity of 6- to 59-month-old children in rural areas of Moramanga and Morondava districts, Madagascar. PLoS One. 2018 Jul 13;13(7):e0200235. doi: 10.1371/journal.pone.0200235. eCollection 2018.

    PMID: 30005067BACKGROUND
  • UNICEF. The state of the world's children: Children, food and nutrition: growing well in a changing world 2019.

    BACKGROUND
  • Wellington MoH. Food and Nutrition Guidelines for Healthy Infants and Toddlers (Aged 0- 2): A background paper (4th Ed) - Partially Revised December 2012

    BACKGROUND
  • Khan JR, Awan N, Misu F. Determinants of anemia among 6-59 months aged children in Bangladesh: evidence from nationally representative data. BMC Pediatr. 2016 Jan 11;16:3. doi: 10.1186/s12887-015-0536-z.

    PMID: 26754288BACKGROUND
  • Widjaja IR, Widjaja FF, Sanotos LA, Wonggokusuma, Oktaviati. Anemia among children and adolescents in a rural area. Paediatr Indones 2014;54(2)

    BACKGROUND
  • Ntenda PAM, Chuang KY, Tiruneh FN, Chuang YC. Multilevel Analysis of the Effects of Individual- and Community-Level Factors on Childhood Anemia, Severe Anemia, and Hemoglobin Concentration in Malawi. J Trop Pediatr. 2018 Aug 1;64(4):267-278. doi: 10.1093/tropej/fmx059.

    PMID: 28977637BACKGROUND
  • Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409.

    PMID: 18297894BACKGROUND

Study Officials

  • Saptawati Bardosono, Doctor

    Indonesian Nutrition Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 11, 2020

Study Start

March 1, 2021

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations