Impact of Fortified Rice on Workers' Nutrition Status
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
133 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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