Effects of Multiple-micronutrients Supplementation on Growth and Iron Status of Indigenous Children in Malaysia

NCT04561635 | Completed DMC

• 1 other identifier: Universiti Putra Malaysia
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Child undernutrition is largely attributed to inadequate nutrition including micronutrient deficiency. Undernutrition is prevalent among indigenous children as compared to the general population. This cluster randomized controlled trial aimed to determine the effect of multiple-micronutrients supplement (MMS) on growth and iron status of Orang Asli (indigenous group in Peninsular Malaysia) young children (6 to 24 months) in Selangor. MMS is a blend of 15 micronutrients in powder form that can be used for home fortification of foods for young children. A total of 98 children recruited in this study with 49 children randomly assigned for each intervention (IG) and control group (CG). At baseline, all children were normal in weight-for-age (WAZ\>-2SD), length-for-age (LAZ\>-2SD), weight-for-length (WLZ\>-2SD) and blood haemoglobin (\>11g/dL). IG was supplemented with three sachets of MMS each week i.e. every other day for 12 months and received health and nutrition advice. CG only received health and nutrition advice. Both groups were assessed for body weight, length and dietary intake at baseline, month 3, 6, 9, 12 of intervention, and 3 months post intervention. Blood haemoglobin was assessed at baseline, month-12 of intervention and 3 months post intervention. Compliance to MMS was measured in IG. The primary outcomes were weight, length, WAZ, LAZ, WLZ and haemoglobin, while the secondary outcome was dietary intake. The independence sample t-test and the chi-square test were used to determine the difference in the baseline variables between the groups. ANOVA using General Linear Model (GLM) for repeated measures was performed to determine the difference in the growth measures z scores, haemoglobin, energy, nutrients and food group within and between the groups over the period of the study. Per protocol analysis was performed. This study hypothesized that there were significant differences in the changes (before and after MMS intervention) related to growth \[(weight-for-age (WAZ), length-for-age (LAZ) and weight-for-length (WLZ)\]; iron status (haemoglobin concentration); and dietary intake (energy, nutrients and food group intakes) between intervention and control groups.

Conditions

Underweight; Stunted Growth; Wasting; Anemia

Keywords

micronutrients supplementation; child underweight; stunted; wasted; anemia

Outcome Measures

Primary Outcomes (6)

• Weight

  kilogram

  One year

• Length

  centimetre

  One year

• Weight-for-age z score

  WAZ

  One year

• Length-for-age z score

  LAZ

  One year

• Weight-for-length z score

  WLZ

  One year

• Iron status

  Haemoglobin concentration

  One year

Secondary Outcomes (11)

• Energy intake

  One year

• Carbohydrate intake

  One year

• Protein intake

  One year

• Fat intake

  One year

• Vitamin A intake

  One year

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group was supplemented with three sachets of MMS each week for every other day for a period of 12 months. Each sachet containing 1 g consisting of ten vitamins and five minerals. It was to be sprinkled over a cooked meal or dissolved in a drink for the child. Written instruction for using and storing the MMS in simple language with visuals was given prior to the supplementation. The intervention group also received health and nutrition advice at 3, 6 and 9 months after supplementation begins.

Dietary Supplement: Multiple-micronutrients supplement

Control group

NO INTERVENTION

The control group received health and nutrition advice that were similar to intervention group and delivered by the investigator at 3, 6 and 9 months after the study began.

Interventions

Multiple-micronutrients supplement DIETARY_SUPPLEMENT

Multiple-micronutrients supplement with 15 micronutrients

Intervention group

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 6 to 24 months old; and
• Normal weight-for-age (WAZ \> -2SD), length-for-age (LAZ \> -2SD) and weight-for-length (WLZ \> -2SD); and
• Normal haemoglobin level (\> 11.0g/dL).

You may not qualify if:

• Has/ had history of chronic diseases e.g. failure to thrive and/or metabolic or endocrine disorders; and
• Has history of congenital and/or acquired neurological condition; and
• Under treatment for communicable diseases such as Tuberculosis, HIV.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Universiti Putra Malaysia

Seri Kembangan, Selangor, 43300, Malaysia

Location

MeSH Terms

Conditions

Thinness; Growth Disorders; Cachexia; Anemia

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Weight Loss; Body Weight Changes; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Nur D Shaari, M.Sc (Nutr)

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 23, 2020
• Study Start: September 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)