The Effect of Multiple Micronutrient Supplements in Reducing Anemia in Women of Reproductive Age

NCT05682261 | Completed DMC

• 1 other identifier: EPHI_IRB_410_2021_2
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the effect of multiple micronutrient supplements in reducing anemia in women of reproductive age in comparison with iron-folic acid. The main questions it aims to answer are:

• What is the effect of multiple micronutrient supplements in reducing anemia among women of reproductive age in comparison with iron-folic acid?
• What is the effect of multiple micronutrient supplements in reducing iron deficiency among women of reproductive age in comparison with iron-folic acid? Participants will
• be given multiple micronutrient supplements, iron folic acid, or placebo twice weekly for 17 weeks
• be asked to respond to the interview
• provide blood, urine, and stool samples Researchers will compare the control group with the intervention groups to see the effect of multiple micronutrient supplements on iron deficiency and anemia reduction.

Conditions

Anemia

Keywords

Multiple Micronutrient Supplements; Iron-folic acid; Anemia; Hemoglobin; Women of reproductive age

Outcome Measures

Primary Outcomes (2)

• Change in mean hemoglobin concentrations among women of reproductive age

  Hemoglobin concentration is measured in gram/deciliter from whole blood samples collected at baseline and end-line.

  Blood sample will be collected once at baseline and once at end-line in four months

• Change in overall anemia among women of reproductive age

  Anemia diagnosed when hemoglobin concentration test result is less than 12 g/dl

  Blood sample will be collected once at baseline and once at end-line in four months

Secondary Outcomes (2)

• Change in mean ferritin concentration among women of reproductive age

  The serum samples will be collected once at the baseline and once at the end-line in four months

• Change in iron deficiency anemia among women of reproductive age

  Blood sample will be collected once at baseline and once at end-line in four months

Study Arms (3)

Multiple micronutrient supplement arm

EXPERIMENTAL

The participants in this arm will receive United Nations International Multiple Micronutrient-Multiple Micronutrient Supplements. The recommended doses of UNIMMAP-MMS are vitamin A as retinol acetate (800 µg RAE), vitamin D as cholecalciferol (5 µg), vitamin E as alpha-tocopherol succinate (10 mg), vitamin C as ascorbic acid (70 mg), vitamin B1 as thiamin mononitrate (1.4 mg), vitamin B2 as riboflavin (1.4 mg), vitamin B3 as nicotinamide (18 mg), vitamin B6 as pyridoxine hydrochloride (1.9 mg), vitamin B12 as cyanocobalamin (2.6 µg), folic acid (680 µg), iron as ferrous fumarate (30 mg), zinc as zinc oxide (15 mg), copper as copper oxide (2 mg), selenium as sodium selenite (65 µg), iodine as potassium iodide (150 µg). The UNIMMAP-MMS in the tablet form will be used. We will give the supplementation twice a week and follow the study participants for 17 weeks.

Dietary Supplement: UNIMMAP-MMS

Iron-folic acid supplement arm

EXPERIMENTAL

The participants in this arm will receive Iron-Folic Acid (IFA) supplements. The recommended doses of iron-folic acid are 30-60 mg of elemental iron and 400 µg of folic acid combined. In this trial, we will use ferrous sulfate with 30 mg of iron and 400 µg of folic acid in the form of capsule. The supplementation will be given to the study subjects twice a week for 17 weeks.

Dietary Supplement: IFA

Control arm

PLACEBO COMPARATOR

The participants in this arm will receive placebos made of sugar (lactose anhydrous). There is no active ingredient in the placebos. The placebos are lactose powder filled in the capsule. We will give placebos twice a week and will follow the study subjects for 17 weeks. The study subjects in this arm will be compensated with UNIMMAP-MMS at the end of the intervention.

Other: Placebo

Interventions

UNIMMAP-MMS DIETARY_SUPPLEMENT

The study participants in this arm will receive the United Nations International Multiple Micronutrient Antenatal Preparation-Multiple Micronutrient Supplements (UNIMMAP-MMS) containing 15 micronutrients including 30 mg of iron and 400 µg of folic acid.

Multiple micronutrient supplement arm

IFA DIETARY_SUPPLEMENT

The study participants in this arm will receive iron-folic acid supplements with 30 mg of iron and 400 µg of folic acid.

Iron-folic acid supplement arm

Placebo OTHER

The study participants in this arm will receive placebo made of sugar (lactose anhydrous).

Control arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: The participants are expected to have the same gender identity as their biological sex.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range of 18-49 years.
• Mildly anemic (Hb=11.0-11.9 g/dl) or moderately anemic (Hb=8.0-10.9 g/dl) woman
• Permanent residents (lived for at least six months in the enumeration area)

You may not qualify if:

• A woman whose age is below or above the age range 18-49 year
• A pregnant woman
• Severely ill and incapacitated woman
• Non-permanent resident in the enumeration area
• Severely anemic (Hb \<8.0 g/dl) woman
• A woman with Hb ≥12 g/dl

Sponsors & Collaborators

• Ethiopian Public Health Institute: lead
• Oklahoma State University: collaborator
• Addis Ababa University: collaborator

Study Sites (1)

Ethiopian Public Health Institute

Addis Ababa, Addis Ababa, 1242, Ethiopia

Location

Related Publications (8)

• Chaparro CM, Suchdev PS. Anemia epidemiology, pathophysiology, and etiology in low- and middle-income countries. Ann N Y Acad Sci. 2019 Aug;1450(1):15-31. doi: 10.1111/nyas.14092. Epub 2019 Apr 22.

  PMID: 31008520 BACKGROUND

• Ahmed F, Khan MR, Akhtaruzzaman M, Karim R, Marks GC, Banu CP, Nahar B, Williams G. Efficacy of twice-weekly multiple micronutrient supplementation for improving the hemoglobin and micronutrient status of anemic adolescent schoolgirls in Bangladesh. Am J Clin Nutr. 2005 Oct;82(4):829-35. doi: 10.1093/ajcn/82.4.829.

  PMID: 16210713 BACKGROUND

• Gebreegziabher T, Stoecker BJ. Iron deficiency was not the major cause of anemia in rural women of reproductive age in Sidama zone, southern Ethiopia: A cross-sectional study. PLoS One. 2017 Sep 12;12(9):e0184742. doi: 10.1371/journal.pone.0184742. eCollection 2017.

  PMID: 28898272 BACKGROUND

• Kassebaum NJ; GBD 2013 Anemia Collaborators. The Global Burden of Anemia. Hematol Oncol Clin North Am. 2016 Apr;30(2):247-308. doi: 10.1016/j.hoc.2015.11.002.

  PMID: 27040955 BACKGROUND

• Multiple Micronutrient Supplement Technical Advisory Group (MMS-TAG); Micronutrient Forum (MNF). Expert consensus on an open-access United Nations International Multiple Micronutrient Antenatal Preparation-multiple micronutrient supplement product specification. Ann N Y Acad Sci. 2020 Jun;1470(1):3-13. doi: 10.1111/nyas.14322. Epub 2020 Mar 9.

  PMID: 32153024 BACKGROUND

• Petry N, Olofin I, Hurrell RF, Boy E, Wirth JP, Moursi M, Donahue Angel M, Rohner F. The Proportion of Anemia Associated with Iron Deficiency in Low, Medium, and High Human Development Index Countries: A Systematic Analysis of National Surveys. Nutrients. 2016 Nov 2;8(11):693. doi: 10.3390/nu8110693.

  PMID: 27827838 BACKGROUND

• Gomes F, Agustina R, Black RE, Christian P, Dewey KG, Kraemer K, Shankar AH, Smith ER, Thorne-Lyman A, Tumilowicz A, Bourassa MW. Multiple micronutrient supplements versus iron-folic acid supplements and maternal anemia outcomes: an iron dose analysis. Ann N Y Acad Sci. 2022 Jun;1512(1):114-125. doi: 10.1111/nyas.14756. Epub 2022 Feb 25.

  PMID: 35218047 BACKGROUND

• Kuche D, Abebe Z, Tessema M, Girma M, Hussen A, Baye K, Stoecker BJ. The effect of UNIMMAP multiple micronutrient supplements versus iron-folic acid and placebo in anemia reduction among women of reproductive age in Kebribeyah Woreda, Somali Regional State, Ethiopia: a study protocol for a community-based individual RCT. Trials. 2024 Mar 6;25(1):170. doi: 10.1186/s13063-024-08024-w.

  PMID: 38448918 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Masresha Tessema, PhD

  Ethiopian Public Health Institute (EPHI)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the current trial, the outcome assessors and study subjects will both be blinded. The supplements being administered to participants, as well as who is in the intervention group and who is in the control group, will be masked from the assessors. The trial participants will be blinded to the kind of supplements being administered to them and the group to which they were assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher for nutrition

Model Details: The three arms included in this trial are the multiple micronutrient supplement arm, iron-folic acid arm, and the placebo arm. This trial is a parallel-group community-based individual randomized control trial. The participants will be allocated randomly to the three arms and receive only the intervention assigned to them.

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: January 12, 2023
• Study Start: March 23, 2023
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: August 7, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)