Anemia Clinical Trial
Official title:
Effects of Multiple-micronutrients Supplementation on Growth and Iron Status of Indigenous Children in Malaysia
Verified date | October 2020 |
Source | Universiti Putra Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | April 30, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 24 Months |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Universiti Putra Malaysia | Seri Kembangan | Selangor |
Lead Sponsor | Collaborator |
---|---|
Universiti Putra Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight | kilogram | One year | |
Primary | Length | centimetre | One year | |
Primary | Weight-for-age z score | WAZ | One year | |
Primary | Length-for-age z score | LAZ | One year | |
Primary | Weight-for-length z score | WLZ | One year | |
Primary | Iron status | Haemoglobin concentration | One year | |
Secondary | Energy intake | kilocalories | One year | |
Secondary | Carbohydrate intake | gram | One year | |
Secondary | Protein intake | gram | One year | |
Secondary | Fat intake | gram | One year | |
Secondary | Vitamin A intake | microgram | One year | |
Secondary | Vitamin C intake | milligram | One year | |
Secondary | Vitamin D intake | microgram | One year | |
Secondary | Folate intake | microgram | One year | |
Secondary | Iron intake | milligram | One year | |
Secondary | Calcium intake | milligram | One year | |
Secondary | Zinc intake | milligram | One year |
Status | Clinical Trial | Phase | |
---|---|---|---|
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