Iron-Biofortified Rice Intervention in the Philippines

Anemia Clinical Trial

Official title:

Randomized Trial of Iron-Biofortified Rice in Women in the Philippines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623918
• Other study ID #: Haas2005
• Status: Completed
• Phase: N/A
• Start date: June 1, 2002
• Est. completion date: December 31, 2003

Study information

• Verified date: November 2020
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. A randomized trial of biofortified rice (IR68144-2B-2-2-3), bred to enhance iron content, was conducted among women living in convents in the greater area of Manila, Philippines for 9 months.

Description:

Iron deficiency is the most prevalent nutritional deficiency globally, with the highest burden in women of reproductive age and children. In this randomized controlled trial, 317 women aged 18-45 years living in convents in the greater Manila area, Philippines, were fed meals using either biofortified or commercially available rice for all meals, 7 days a week, for 9 months. Women living in convents in the greater Manila area were recruited for this study. These women represent a segment of the population at high risk for iron deficiency, consume large quantities of rice, and all of their meals are prepared and consumed in common kitchen and dining areas, respectively.

The investigators hypothesized that daily consumption of iron-biofortified rice (IR68144-2B-2-2-3) would improve hemoglobin, serum ferritin, and total body iron in 9 months, compared to control rice. In order to examine this hypothesis, the investigators conducted a randomized efficacy trial of iron-biofortified rice and iron status in among women living in convents in the greater area of Manila, Philippines for 9 months.

The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice.

The long-term goal of this study is to determine if iron bio-fortification of rice is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: December 31, 2003
• Est. primary completion date: December 31, 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women (18-45 years old) living in convents in the greater Manila area

• Hb =10.5 g/dL

Exclusion Criteria:

• Current or history of gastrointestinal or hematological disorders

• Taking iron supplements or medications that could interfere with hematopoiesis or dietary iron absorption

• Hb <10.5 g/dL

• Women expressed uncertainty in their ability to participate for the full (9 month) trial

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

Other:
• Iron-biofortified rice
Iron-biofortified rice (IR68144-2B-2-2-3)
• Control rice
Control rice (C4), identical in appearance

Locations

Country	Name	City	State
Philippines	University of the Philippines	Los Baños	Laguna

Sponsors (3)

Lead Sponsor	Collaborator
Cornell University	Penn State University, University of the Philippines

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

Haas JD, Beard JL, Murray-Kolb LE, del Mundo AM, Felix A, Gregorio GB. Iron-biofortified rice improves the iron stores of nonanemic Filipino women. J Nutr. 2005 Dec;135(12):2823-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum ferritin	Serum ferritin (SF)	9 months
Primary	Change in sTfR	Soluble transferrin receptor (sTfR)	9 months
Primary	Change in TBI	Total body iron (TBI)	9 months
Secondary	Change in hemoglobin among women who were anemic at baseline	Changes in hemoglobin (Hb) in women who were anemic at baseline	9 months
Secondary	Changes in SF among women who were non-anemic at baseline	Changes in SF among women who were non-anemic at baseline	9 months
Secondary	Changes in sTfR among women who were non-anemic at baseline	Changes in sTfR among women who were non-anemic at baseline	9 months
Secondary	Changes in TBI among women who were non-anemic at baseline	Changes in TBI among women who were non-anemic at baseline	9 months