Study to Evaluate the Efficacy of Fortified Rice on Hemoglobin Levels and Levels of Vitamins and Minerals in Healthy Asian Migrant Workers in Singapore
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 133
- Locations
- 2
- Primary Endpoint
- Hemoglobin status
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Hemoglobin status
Time Frame: From baseline to 6 months
Hemoglobin concentration in blood
Secondary Outcomes
- Zinc status(From baseline to 6 months)
- Homocysteine status(From baseline to 6 months)
- BMI(From baseline to 6 months)
- Folate status(From baseline to 6 months)
- Iron status(From baseline to 6 months)
- Vitamin B12 status(From baseline to 6 months)
