Culturally appropriate iron biscuits for pregnant women

Proposal Title:

Proof of Concept of a Culturally Appropriate Iron Fortified Biscuit to Reduce Maternal and Perinatal Anemia

Country of Implementation:

India

Sites:

St. John’s Research Institute and St. John’s Medical College-Hospital, Bangalore

Rural/Urban:

Rural, Urban & Peri-Urban

Target Beneficiary:

Pregnant Women; -9 to 0 Months

Objective:

To reduce anemia in pregnant women and subsequently increase iron stores in newborns.

Innovation Description:

The creation of a culturally-acceptable iron-fortified biscuit as a desirable alternative to iron pills for pregnant women.

Stage of Innovation:

Proof of Concept

Culturally appropriate iron biscuits for pregnant women

Proposal Title

Proof of Concept of a Culturally Appropriate Iron Fortified Biscuit to Reduce Maternal and Perinatal Anemia

Sites

St. John’s Research Institute and St. John’s Medical College-Hospital, Bangalore

Rural/Urban

Rural, Urban & Peri-Urban

Target Beneficiary

Pregnant Women; -9 to 0 Months

Objective

To reduce anemia in pregnant women and subsequently increase iron stores in newborns.

Innovation Description

The creation of a culturally-acceptable iron-fortified biscuit as a desirable alternative to iron pills for pregnant women.

Stage of Innovation

Proof of Concept

Innovation Summary

0348_IN-St-Johns-Research-Institute

India’s anemia rates are among the highest globally: over 79% of children aged 6 to 8 months have anemia; 58% of the 26 million women who are pregnant each year are diagnosed with anemia.  Although more than 17 million of these women have access to iron pills, 11 million do not take them for the recommended time (an adherence rate of only 35%)[1]. Based on research and market studies with Indian pregnant women, key reasons the adherence rate is so low are the pill’s side effects and that pregnant women do not like to swallow iron pills, because of their size and taste.

This innovation is to create an iron-fortified biscuit for pregnant women who would otherwise be non-adherent to iron pills, indistinguishable in taste from popular Indian biscuits. The innovation seeks to prove the acceptability of this prototype by pregnant women, equivalent bioavailability of the iron biscuit to the pill, and the efficacy of the iron-fortified biscuit. The results will help to better position the product for scale, and in turn reduce the burden of perinatal anemia.

Impact

118 women will have access to iron fortification during pregnancy (half to traditional iron pills, and half to the intervention biscuits).

We aim to prove our solution to be as efficacious as an iron pill, while reaching more anemic women and their children.
-- Dr. Pratibha Dwarkanath, St. John’s Research Institute, CBCI Society for Medical Education, co – Co-PI of project

Innovation

The overarching goal of this innovation is to encourage pregnant women to consume iron supplements, to increase her and her baby’s iron stores. Given the lack of adherence to iron pills, the team has developed several prototypes of iron-fortified biscuits specifically tailored to the tastes and preferences of pregnant women in India. Multiple flavors have been created after extensive market research.  The biscuits are indistinguishable in taste from typical biscuits which are consumed habitually by many pregnant women.

Three studies will be conducted with the following goals:

  1. To examine women’s preferences during pregnancy for consuming oral iron supplementation in the form of a biscuit or the traditional iron pill.
  2. To prove bioavailability of iron from the prototype biscuit compared to the traditional iron pill.
  3. To demonstrate efficacy of the iron biscuit, hypothesizing it to be as effective, if not superior, to the iron pill.

Collaboration

Implementation

Key Drivers

Leadership & Experience

The project team brings together public health acumen, business start-up experience, clinical research knowledge and experience, and close relationships with public health/clinical product researchers, advisors in consumer packaged goods companies, government programs, and pharmaceuticals in India.

Researchers and physicians at St. John’s Research Institute have immense experience in successfully designing, conducting and implementing scientific research.

Continuation

Within three years, after the proof of concept stage, we anticipate a scaled trial in the Indian state of Karnataka to test the increased adherence of the iron-fortified biscuit.

Evaluation Methods

Since the approach consists of three different studies, three evaluations will be conducted:

  1. Preference study — determined by an observational, cross-sectional study.
  2. Bioavailability Trial — evaluated using a randomized, crossover design.
  3. Efficacy Trial — evaluated using a double-blind, randomized control trial.

Through these trials, the following outcomes will be assessed:

  • Hemoglobin/serum iron, as biomarkers for prevention/reduction of anemia in pregnant women and predictors for healthy births and infants’ iron stores.

Impact of Innovation

We estimate our solution to be more cost-effective than the iron pill (at approximately $13 per disability-adjusted life year) while reaching more anemic women and their children. [2]

References

  1. International Institute for Population Sciences (IIPS) and Macro International. 2007. National Family Health Survey (NFHS – 3), 2005-2006: India: Volume I. Mumbai: IIPS. P198.
  2. Hunt, J. (2002) Reversing productivity losses from iron deficiency: The economic case. Journal of Nutrition, 132: 794S-801S.

Resources

Saving Brains is a partnership of

Saving Brains is a partnership of