Fermented Iron-rich Supplement in Reducing Anemia

NCT02037724 | Unknown Phase 2

• 1 other identifier: UG-0001-IDA
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• comparison of side effects of iron supplement

  3 months

Other Outcomes (1)

• minimum level of supplement intake needed to improve iron status

  3 months

Study Arms (4)

supplement containing 60 mg iron sulfate

OTHER

nutrient supplement containing 60 mg of iron as ferous 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

iron rich food supplement (60 mg iron)

EXPERIMENTAL

contains 60 mg Iron

Dietary Supplement: supplement containing 60 mg iron sulfate; Dietary Supplement: iron rich food supplement (10 mg iron); Dietary Supplement: supplement containing 10 mg iron sulfate

iron rich food supplement (10 mg iron)

EXPERIMENTAL

contains 10 mg of iron

Dietary Supplement: supplement containing 60 mg iron sulfate; Dietary Supplement: iron rich food supplement (60 mg iron); Dietary Supplement: supplement containing 10 mg iron sulfate

supplement containing 10 mg iron sulfate

OTHER

nutrient supplement containing 10 mg of iron as ferous sulfate

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)

Interventions

supplement containing 60 mg iron sulfate DIETARY_SUPPLEMENT

control agent

iron rich food supplement (10 mg iron); iron rich food supplement (60 mg iron); supplement containing 10 mg iron sulfate

iron rich food supplement (60 mg iron) DIETARY_SUPPLEMENT

contains 60 mg of iron

iron rich food supplement (10 mg iron); supplement containing 10 mg iron sulfate; supplement containing 60 mg iron sulfate

iron rich food supplement (10 mg iron) DIETARY_SUPPLEMENT

contains 10 mg iron

iron rich food supplement (60 mg iron); supplement containing 10 mg iron sulfate; supplement containing 60 mg iron sulfate

supplement containing 10 mg iron sulfate DIETARY_SUPPLEMENT

control agent

iron rich food supplement (10 mg iron); iron rich food supplement (60 mg iron); supplement containing 60 mg iron sulfate

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• history of gastrointestinal or hematological disorders,
• taking medications that could interfere with hematopoiesis or dietary iron absorption
• pregnant (based on pregnancy test).

Sponsors & Collaborators

• University of Ghana: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Iron-Dextran Complex; Iron

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Richmond Aryeetey, PhD

  University of Ghana

  PRINCIPAL INVESTIGATOR

• Manju Reddy, PhD

  Iowa State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richmond Aryeetey, PhD

CONTACT

233244129669; raryeetey@ug.edu.gh

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 16, 2014

Record last verified: 2014-01