Fermented Iron-rich Supplement in Reducing Anemia

Iron Deficiency Anemia Clinical Trial

— FISRA  

Official title:

Fermented Iron-rich Supplement in Reducing Anemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02037724
• Other study ID #: UG-0001-IDA
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 14, 2014
• Last updated: January 14, 2014
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: January 2014
• Source: University of Ghana
• Contact: Richmond Aryeetey, PhD
• Phone: 233244129669
• Email: raryeetey[@]ug.edu.gh
• Is FDA regulated: No
• Health authority: Ghana : Food and Drugs Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• supplement containing 60 mg iron sulfate
control agent
• iron rich food supplement (60 mg iron)
contains 60 mg of iron
• iron rich food supplement (10 mg iron)
contains 10 mg iron
• supplement containing 10 mg iron sulfate
control agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Ghana

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	minimum level of supplement intake needed to improve iron status	The effectiveness of low dose (10 mg daily iron) compared to higher dose (60mg daily iron) from the fermented organic food supplement product. These results will be helpful for using IRS as a food supplement.	3 months	No
Primary	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	No
Secondary	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	Yes