Nutrient Deficiency
Conditions
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.
Interventions
OTHERFortified 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).
Sponsors
Sprim Advanced Life Sciences
DSM Nutritional Products, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin status | From baseline to 6 months | Hemoglobin concentration in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Zinc status | From baseline to 6 months | Serum zinc concentration |
| Folate status | From baseline to 6 months | Red blood cell folate concentration in serum |
| Iron status | From baseline to 6 months | Serum ferritin concentration |
| Vitamin B12 status | From baseline to 6 months | Serum vitamin B12 concentration |
| Homocysteine status | From baseline to 6 months | Serum homocysteine concentration |
| BMI | From baseline to 6 months | BMI calculated from height and weight |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | From baseline to 6 months | Systolic and Diastolic Blood Pressure (mmHg) |
| Pulse | From baseline to 6 months | Pulse (count/min) |
| Body temperature | From baseline to 6 months | Body temperature (degrees Celsius) |
| Weight | From baseline to 6 months | Weight (kg) |
| Height | From baseline to 6 months | Height (cm) |
Countries
Singapore
Outcome results
None listed