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

Primary Purpose

Anemia

Status
Active
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
UNIMMAP-MMS
IFA
Placebo
Sponsored by
Ethiopian Public Health Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Multiple Micronutrient Supplements, Iron-folic acid, Anemia, Hemoglobin, Women of reproductive age

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • Ethiopian Public Health Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Multiple micronutrient supplement arm

Iron-folic acid supplement arm

Control arm

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
Change in overall anemia among women of reproductive age
Anemia diagnosed when hemoglobin concentration test result is less than 12 g/dl

Secondary Outcome Measures

Change in mean ferritin concentration among women of reproductive age
Ferritin concentration is measured from serum ferritin in µg/L.
Change in iron deficiency anemia among women of reproductive age
Iron deficiency anemia is diagnosed when hemoglobin concentration test result is less than 12 g/dl and the ferritin concentration test result is less than 15 µg/L

Full Information

First Posted
December 4, 2022
Last Updated
September 5, 2023
Sponsor
Ethiopian Public Health Institute
Collaborators
Oklahoma State University, Addis Ababa University
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1. Study Identification

Unique Protocol Identification Number
NCT05682261
Brief Title
The Effect of Multiple Micronutrient Supplements in Reducing Anemia in Women of Reproductive Age
Official Title
The Effect of Multiple Micronutrient Supplements in Reducing Anemia Among Women of Reproductive Age Compared to Iron-folic Acid at Kebribeyah District in Somali Regional State, Ethiopia- A Community-based Individual Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ethiopian Public Health Institute
Collaborators
Oklahoma State University, Addis Ababa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Women in developing countries are often at risk of micronutrient deficiencies due to inadequate micronutrient intake. Since various micronutrient deficiencies co-exist, multiple micronutrient supplements are recommended to combat their deficiencies. The purpose of this study is to assess the effects of multiple micronutrient supplements among women of reproductive age in reducing anemia compared with iron-folic acid as currently practiced in Ethiopia. The current study is a community-based individual randomized placebo-controlled trial. The trial is double blinded with three parallel groups. This trial will be conducted in three randomly selected kebeles (villages) in the Kebribeyah district in the Somali regional state. The sample size determined for this study is 305. There will be two intervention arms and one control arm in this trial. A third of participants will be in each arms. The intervention arms will will be supplemented with United Nations International Multiple Micronutrient Antenatal Preparation-Multiple Micronutrient Supplements (UNIMMAP-MMS) or iron-folic acid (IFA) and the control arm with placebos twice a week. The investigators will follow the study participants for 17 weeks. The primary outcome is a change in mean hemoglobin concentrations and reduction in anemia prevalence. Stratified randomization will be used to assign the participants randomly to the study arms. 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 or the group to which they were assigned. The allocation sequence of participants will be concealed from the researcher who will assign the participants to the study arms. When the eligible woman meets the screening criteria and gives informed consent, she will be assigned an envelope that contains an allocation sequence. As outcome measures, the investigators will assess the reduction in overall anemia and iron deficiency anemia attributable to the supplementation. In addition, a complete blood count (CBC) will be tested for all study participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Multiple Micronutrient Supplements, Iron-folic acid, Anemia, Hemoglobin, Women of reproductive age

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple micronutrient supplement arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Iron-folic acid supplement arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
UNIMMAP-MMS
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
IFA
Intervention Description
The study participants in this arm will receive iron-folic acid supplements with 30 mg of iron and 400 µg of folic acid.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The study participants in this arm will receive placebo made of sugar (lactose anhydrous).
Primary Outcome Measure Information:
Title
Change in mean hemoglobin concentrations among women of reproductive age
Description
Hemoglobin concentration is measured in gram/deciliter from whole blood samples collected at baseline and end-line.
Time Frame
Blood sample will be collected once at baseline and once at end-line in four months
Title
Change in overall anemia among women of reproductive age
Description
Anemia diagnosed when hemoglobin concentration test result is less than 12 g/dl
Time Frame
Blood sample will be collected once at baseline and once at end-line in four months
Secondary Outcome Measure Information:
Title
Change in mean ferritin concentration among women of reproductive age
Description
Ferritin concentration is measured from serum ferritin in µg/L.
Time Frame
The serum samples will be collected once at the baseline and once at the end-line in four months
Title
Change in iron deficiency anemia among women of reproductive age
Description
Iron deficiency anemia is diagnosed when hemoglobin concentration test result is less than 12 g/dl and the ferritin concentration test result is less than 15 µg/L
Time Frame
Blood sample will be collected once at baseline and once at end-line in four months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The participants are expected to have the same gender identity as their biological sex.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masresha Tessema, PhD
Organizational Affiliation
Ethiopian Public Health Institute (EPHI)
Official's Role
Study Director
Facility Information:
Facility Name
Ethiopian Public Health Institute
City
Addis Ababa
ZIP/Postal Code
1242
Country
Ethiopia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not currently have any plans to provide access to individual participant data. We may share the data once the key findings have been published. In addition, we need to obtain approval from the officials of the Ethiopian Public Health Institute.
Citations:
PubMed Identifier
31008520
Citation
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.
Results Reference
background
PubMed Identifier
16210713
Citation
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.
Results Reference
background
PubMed Identifier
28898272
Citation
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. Erratum In: PLoS One. 2017 Dec 7;12 (12 ):e0189553.
Results Reference
background
PubMed Identifier
27040955
Citation
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.
Results Reference
background
PubMed Identifier
32153024
Citation
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.
Results Reference
background
PubMed Identifier
27827838
Citation
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.
Results Reference
background
PubMed Identifier
35218047
Citation
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.
Results Reference
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The Effect of Multiple Micronutrient Supplements in Reducing Anemia in Women of Reproductive Age

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