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Completed

NCT Number: NCT04343508

Impact of Fortified Rice on Workers' Nutrition Status

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.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

SPRIM

Singapore, 118264

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fortified rice

Other

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).

Primary outcomes

  1. Hemoglobin status

    Time frame: From baseline to 6 months

    Hemoglobin concentration in blood

Secondary outcomes

  1. Folate status

    Time frame: From baseline to 6 months

    Red blood cell folate concentration in serum

  2. Zinc status

    Time frame: From baseline to 6 months

    Serum zinc concentration

  3. Iron status

    Time frame: From baseline to 6 months

    Serum ferritin concentration

  4. Vitamin B12 status

    Time frame: From baseline to 6 months

    Serum vitamin B12 concentration

  5. Homocysteine status

    Time frame: From baseline to 6 months

    Serum homocysteine concentration

  6. BMI

    Time frame: From baseline to 6 months

    BMI calculated from height and weight

Other outcomes

  1. Height

    Time frame: From baseline to 6 months

    Height (cm)

  2. Weight

    Time frame: From baseline to 6 months

    Weight (kg)

  3. Blood pressure

    Time frame: From baseline to 6 months

    Systolic and Diastolic Blood Pressure (mmHg)

  4. Pulse

    Time frame: From baseline to 6 months

    Pulse (count/min)

  5. Body temperature

    Time frame: From baseline to 6 months

    Body temperature (degrees Celsius)

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Collaborators

  • Sprim Advanced Life Sciences

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2020
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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