NCT04561635

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

Completed NA Last updated 9 October 2020

What this trial tests

NA trial testing Multiple-micronutrients supplement in Underweight in 98 participants. Completed in 30 April 2019.

Timeline

1 September 2017

Primary endpoint
30 April 2019

30 April 2019

Quick facts

Lead sponsor	Universiti Putra Malaysia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	98
Start date	1 September 2017
Primary completion	30 April 2019
Estimated completion	30 April 2019
Sites	1 location across Malaysia

Drugs / interventions tested

• Multiple-micronutrients supplement

Conditions studied

• Underweight — all drugs for Underweight →
• Stunted Growth — all drugs for Stunted Growth →
• Wasting — all drugs for Wasting →
• Anemia — all drugs for Anemia →

Sponsor

Universiti Putra Malaysia — full company profile →

Who can join

Adults 6 Months to 24 Months, any sex, with Underweight or Stunted Growth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.