Clinical trial NCT04623918: Iron-Biofortified Rice Intervention in the Philippines
Official title: Randomized Trial of Iron-Biofortified Rice in Women in the Philippines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Anemia
Keywords: Anemia
Iron
Biofortification
Philippines
Iron deficiency
Women of reproductive age
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Penn State University
name: University of the Philippines
First posted: 2020-11-10
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in serum ferritin
timeFrame: 9 months
measure: Change in sTfR
timeFrame: 9 months
measure: Change in TBI
timeFrame: 9 months
Secondary outcomes:
measure: Change in hemoglobin among women who were anemic at baseline
timeFrame: 9 months
measure: Changes in SF among women who were non-anemic at baseline
timeFrame: 9 months
measure: Changes in sTfR among women who were non-anemic at baseline
timeFrame: 9 months
measure: Changes in TBI among women who were non-anemic at baseline
timeFrame: 9 months
Other outcomes:
Locations:
city: Los Baños
country: Philippines
facility: University of the Philippines
state: Laguna
Study officials:
affiliation: Cornell University
name: Jere Haas
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/jn/135.12.2823.