Impact of Fortified Rice on Workers' Nutrition Status
Study to Evaluate the Efficacy of Fortified Rice on Hemoglobin Levels and Levels of Vitamins and Minerals in Healthy Asian Migrant Workers in Singapore
1 other identifier
interventional
133
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedFirst Submitted
Initial submission to the registry
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedFebruary 9, 2021
February 1, 2021
7 months
April 9, 2020
February 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin status
Hemoglobin concentration in blood
From baseline to 6 months
Secondary Outcomes (6)
Folate status
From baseline to 6 months
Zinc status
From baseline to 6 months
Iron status
From baseline to 6 months
Vitamin B12 status
From baseline to 6 months
Homocysteine status
From baseline to 6 months
- +1 more secondary outcomes
Other Outcomes (5)
Height
From baseline to 6 months
Weight
From baseline to 6 months
Blood pressure
From baseline to 6 months
- +2 more other outcomes
Study Arms (1)
Fortified rice
EXPERIMENTALfortified rice for daily lunch and dinner each day of the week (i.e. 14 meals/week) for six months
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DSM Nutritional Products, Inc.lead
- Sprim Advanced Life Sciencescollaborator
Study Sites (1)
SPRIM
Singapore, 118264, Singapore
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2020
First Posted
April 13, 2020
Study Start
March 11, 2018
Primary Completion
September 30, 2018
Study Completion
September 30, 2018
Last Updated
February 9, 2021
Record last verified: 2021-02