Fermented Iron-rich Supplement in Reducing Anemia

Study Overview
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Brief Summary
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The consequences of iron deficiency anemia in women are enormous, and especially in developing countries, as the condition adversely affects both their productive and reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators among women receiving an iron-rich organic food supplement versus ferrous sulfate supplement, and 2) determine the suitable level of food supplement needed to prevent/reduce iron deficiency anemia among women in developing country settings. A double-blind, randomized, controlled, intervention trial will be implemented in women of childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency. After screening potential subjects (up to 500 expected), approximately 30 will be recruited into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in ferritin as significant between the two time points at 80% power and alpha value of 0.05. Subjects who meet the inclusion criteria will be randomized into the four groups consisting of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8 weeks while subjects taking FS-10 and IRS-10 will take the supplement under supervision for 12 consecutive weeks.

Detailed Description
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The design will involve screening of about 500 female adult students and staff of the University of Ghana who meet initial the inclusion criteria. Screening will involve pregnancy testing, assessment of hemoglobin, and ferritin and also administration of a health history questionnaire. Thereafter, 120 eligible subjects will enrolled and randomized to recieve the treatment. All subjects will complete 3-day dietary record (including 2 weekdays and 1 weekend) at baseline and at endline (i.e. one week prior to treatment completion). The dietary data will be analyzed using nationally-generated food composition tables together with the ESHA food processor software. In addition, body weight and height will be measured using standard methods at baseline and end of the study. Weekly monitoring of side effects will be recorded. Fasting blood samples will be collected at baseline and endline to enable determination of anemia status and other indicators including serum ferritin, transferrin receptor and full blood count, together with C-reactive protein.

Official Title
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Fermented Iron-rich Supplement in Reducing Anemia

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Dietary Supplement: supplement containing 60 mg iron sulfate
* Dietary Supplement: iron rich food supplement (60 mg iron)
* Dietary Supplement: iron rich food supplement (10 mg iron)
* Dietary Supplement: supplement containing 10 mg iron sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-49 years Regular menstruation in the last three months Hemoglobin <12 mg/dl; Serum Ferittin<20mcg/L BMI 18.5Kg/m^2 to 29.9 kg/m^2 Exclusion Criteria: history of gastrointestinal or hematological disorders, taking medications that could interfere with hematopoiesis or dietary iron absorption pregnant (based on pregnancy test).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: supplement containing 60 mg iron sulfate<br>nutrient supplement containing 60 mg of iron as ferous sulfate | Dietary Supplement: iron rich food supplement (60 mg iron)<br>* contains 60 mg of iron<br>Dietary Supplement: iron rich food supplement (10 mg iron)<br>* contains 10 mg iron<br>Dietary Supplement: supplement containing 10 mg iron sulfate<br>* control agent<br>|
| Experimental: iron rich food supplement (60 mg iron)<br>contains 60 mg Iron | Dietary Supplement: supplement containing 60 mg iron sulfate<br>* control agent<br>Dietary Supplement: iron rich food supplement (10 mg iron)<br>* contains 10 mg iron<br>Dietary Supplement: supplement containing 10 mg iron sulfate<br>* control agent<br>|
| Experimental: iron rich food supplement (10 mg iron)<br>contains 10 mg of iron | Dietary Supplement: supplement containing 60 mg iron sulfate<br>* control agent<br>Dietary Supplement: iron rich food supplement (60 mg iron)<br>* contains 60 mg of iron<br>Dietary Supplement: supplement containing 10 mg iron sulfate<br>* control agent<br>|
| Other: supplement containing 10 mg iron sulfate<br>nutrient supplement containing 10 mg of iron as ferous sulfate | Dietary Supplement: supplement containing 60 mg iron sulfate<br>* control agent<br>Dietary Supplement: iron rich food supplement (60 mg iron)<br>* contains 60 mg of iron<br>Dietary Supplement: iron rich food supplement (10 mg iron)<br>* contains 10 mg iron<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iron deficiency anemia | Improvement of iron status with 60 mg (after two months) and 10 mg iron (after 3 months) will be assessed. The iron status measurements include, hemoglobin, ferritin, transferrin receptor and whole blood count | two and three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of side effects of iron supplement | We expect to have less side effects with IRS compared with ferrous sulfate (as observed in previous studies) that include: constipation, diarrhea, vomiting, gastrointestinal distress, change in stool color and others. We will assess these with a questionnaire. | 3 months |