Clinical trial NCT04343508: Impact of Fortified Rice on Workers' Nutrition Status
Official title: Study to Evaluate the Efficacy of Fortified Rice on Hemoglobin Levels and Levels of Vitamins and Minerals in Healthy Asian Migrant Workers in Singapore
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrient Deficiency
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2020-04-13
Enrollment: 133
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Hemoglobin status
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Folate status
timeFrame: From baseline to 6 months
measure: Zinc status
timeFrame: From baseline to 6 months
measure: Iron status
timeFrame: From baseline to 6 months
measure: Vitamin B12 status
timeFrame: From baseline to 6 months
measure: Homocysteine status
timeFrame: From baseline to 6 months
measure: BMI
timeFrame: From baseline to 6 months
Other outcomes:
measure: Height
timeFrame: From baseline to 6 months
measure: Weight
timeFrame: From baseline to 6 months
measure: Blood pressure
timeFrame: From baseline to 6 months
measure: Pulse
timeFrame: From baseline to 6 months
measure: Body temperature
timeFrame: From baseline to 6 months
Locations:
city: Singapore
country: Singapore
facility: SPRIM
Study officials:
References: