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Clinical Trials/NCT04343508
NCT04343508CompletedNot Applicable

Study to Evaluate the Efficacy of Fortified Rice on Hemoglobin Levels and Levels of Vitamins and Minerals in Healthy Asian Migrant Workers in Singapore

DSM Nutritional Products, Inc.2 sites in 1 country133 target enrollmentStarted: March 11, 2018Last updated:
Conditions

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)

Investigators

Sponsor
DSM Nutritional Products, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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