Clinical trial NCT02037724: Fermented Iron-rich Supplement in Reducing Anemia
Official title: Fermented Iron-rich Supplement in Reducing Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Iron Deficiency Anemia
Lead sponsor: University of Ghana
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: iron deficiency anemia
timeFrame: two and three months
Secondary outcomes:
measure: comparison of side effects of iron supplement
timeFrame: 3 months
Other outcomes:
measure: minimum level of supplement intake needed to improve iron status
timeFrame: 3 months
Locations:
Study officials:
affiliation: University of Ghana
name: Richmond Aryeetey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iowa State University
name: Manju Reddy, PhD
role: PRINCIPAL_INVESTIGATOR
References: