Clinical trial NCT05682261: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anemia
Keywords: Multiple Micronutrient Supplements
Iron-folic acid
Anemia
Hemoglobin
Women of reproductive age
Lead sponsor: Ethiopian Public Health Institute
Sponsor class: OTHER_GOV
Collaborators: name: Oklahoma State University
name: Addis Ababa University
First posted: 2023-01-12
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in mean hemoglobin concentrations among women of reproductive age
timeFrame: Blood sample will be collected once at baseline and once at end-line in four months
measure: Change in overall anemia among women of reproductive age
timeFrame: Blood sample will be collected once at baseline and once at end-line in four months
Secondary outcomes:
measure: Change in mean ferritin concentration among women of reproductive age
timeFrame: The serum samples will be collected once at the baseline and once at the end-line in four months
measure: Change in iron deficiency anemia among women of reproductive age
timeFrame: Blood sample will be collected once at baseline and once at end-line in four months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Ethiopian Public Health Institute
Study officials:
affiliation: Ethiopian Public Health Institute (EPHI)
name: Masresha Tessema, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.