Impact of Fortified Rice on Workers' Nutrition Status

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Nutrient Deficiency

Intervention / Treatment
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* Other: Fortified rice


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fortified rice<br>fortified rice for daily lunch and dinner each day of the week (i.e. 14 meals/week) for six months | Other: Fortified rice<br>* 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).<br>|

What is the study measuring?
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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 |