Impact of Fortified Rice on Workers' Nutrition Status

Study to Evaluate the Efficacy of Fortified Rice on Hemoglobin Levels and Levels of Vitamins and Minerals in Healthy Asian Migrant Workers in Singapore

The study is a single center, open label, nutrition intervention study. Healthy adult male working at a Singapore construction site are included if they fulfill inclusion and exclusion criteria. Volunteers receive fortified rice for their daily lunch and dinner each day of the week (i e 14 meals/week) over six months. Nutrition status in blood is measured at baseline and after six months of fortified rice consumption.

Study Overview

• Status: Completed
• Conditions: Nutrient Deficiency
• Intervention / Treatment: Other: Fortified rice

Detailed Description

The study is a single center, open label, uncontrolled longitudinal nutrition intervention study. Migrant construction workers of either Bangladeshi or Indian ethnicity from a single dormitory in Singapore volunteer to participate at the study. Only eligible workers are included in the study if they fulfilled all inclusion and exclusion criteria; 20 and 51 years old, a BMI between 17.0 to 27.5 kg/m2, willing to adhere to the study procedure for at least six months, and sign informed consent, are free of current medical and/or chronic/non communicable diseases, no history of heavy smoking or alcohol consumption. The eligible subjects receive fortified rice for their daily lunch and dinner each day of the week (i e 14 meals/week) over six months. The nutrient levels per 100 g fortified rice contain 150 µg vitamin A (Vitamin A palmitate), 0.5 mg vitamin B1 (thiamin mononitrate), 7 mg vitamin B3 (niacin amide), 0.6 mg vitamin B6 (pyridoxine hydrochloride), 1 µg vitamin B12 (cyanocobalamin), 130 µg folic acid, 4 mg iron (ferric pyrosphosphate), and 6 mg zinc (zinc oxide). At baseline and after 6 months of intervention, BMI and vital signs such as blood pressure, pulse and body temperature are collected. Also, 10 ml venous blood is sampled at baseline and after 6 months of intervention and subsequently tested for hemoglobin, serum folate, and serum zinc, serum ferritin and serum vitamin B12 status. In a small subset of the migrant construction workers, an extra 5 ml blood sample is taken for homocysteine testing.

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 118264
    • SPRIM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 20 Years to 51 Years
• Indian or Bangladeshi ethnic origin
• BMI of 17.0 to 27.5 kg/m2
• Working at the construction site and continuing for 6 months after enrollment
• Willing and able to adhere to study procedures
• Signed the informed consent form

Exclusion Criteria:

• Conditions or diseases that the investigator considers to be not appropriate to enter the study
• Chronic illness
• History of heavy smoking (more than 10 cigarettes/day continuously for two years or more (self-reported) )
• Unable to understand informed consent (translated to Tamil and Bangladesh at basic literacy level)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fortified rice; fortified rice for daily lunch and dinner each day of the week (i.e. 14 meals/week) for six months	Other: Fortified rice; 100 g of rice was fortified with 150 µg vitamin A (Vitamin A palmitate), 0.5 mg vitamin B1 (thiamin mononitrate), 7 mg vitamin B3 (niacin amide), 0.6 mg vitamin B6 (pyrodoxine hydrochloride), 1 µg vitamin B12 (cyanocobalamin), 130 µg folic acid, 4 mg iron (ferric pyrosphosphate), and 6 mg zinc (zinc oxide).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin status	Hemoglobin concentration in blood	From baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Folate status	Red blood cell folate concentration in serum	From baseline to 6 months
Zinc status	Serum zinc concentration	From baseline to 6 months
Iron status	Serum ferritin concentration	From baseline to 6 months
Vitamin B12 status	Serum vitamin B12 concentration	From baseline to 6 months
Homocysteine status	Serum homocysteine concentration	From baseline to 6 months
BMI	BMI calculated from height and weight	From baseline to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height (cm)	From baseline to 6 months
Weight	Weight (kg)	From baseline to 6 months
Blood pressure	Systolic and Diastolic Blood Pressure (mmHg)	From baseline to 6 months
Pulse	Pulse (count/min)	From baseline to 6 months
Body temperature	Body temperature (degrees Celsius)	From baseline to 6 months

Collaborators and Investigators

• Sponsor: DSM Nutritional Products, Inc.
• Collaborators: Sprim Advanced Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: OBVO-0104DSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No