Impact of Fortified Rice on Workers' Nutrition Status

Nutrient Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343508
• Other study ID #: OBVO-0104DSM
• Status: Completed
• Phase: N/A
• Start date: March 11, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: February 2021
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Nutrient Deficiency

Intervention

Other:
• Fortified 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).

Locations

Country	Name	City	State
Singapore	SPRIM	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.	Sprim Advanced Life Sciences

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Height	Height (cm)	From baseline to 6 months
Other	Weight	Weight (kg)	From baseline to 6 months
Other	Blood pressure	Systolic and Diastolic Blood Pressure (mmHg)	From baseline to 6 months
Other	Pulse	Pulse (count/min)	From baseline to 6 months
Other	Body temperature	Body temperature (degrees Celsius)	From baseline to 6 months
Primary	Hemoglobin status	Hemoglobin concentration in blood	From baseline to 6 months
Secondary	Folate status	Red blood cell folate concentration in serum	From baseline to 6 months
Secondary	Zinc status	Serum zinc concentration	From baseline to 6 months
Secondary	Iron status	Serum ferritin concentration	From baseline to 6 months
Secondary	Vitamin B12 status	Serum vitamin B12 concentration	From baseline to 6 months
Secondary	Homocysteine status	Serum homocysteine concentration	From baseline to 6 months
Secondary	BMI	BMI calculated from height and weight	From baseline to 6 months