Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

Study Overview
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Brief Summary
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This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron.

Official Title
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Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Iron Doseages During Pregnancy in Tanzania

Conditions
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Pregnancy Related

Intervention / Treatment
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* Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron
* Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron
* Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Attending first ANC visit at the study clinic Pregnant women ≤ 15 weeks of gestation Aged ≥ 18 years Intending to stay in Dar es Salaam for the duration of study Provides informed consent Exclusion Criteria: Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care) Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC Concurrent participation in other nutritional supplementation trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each participant will be randomized to one of 6 sequence orders to receive the three MMS regimens first, second or third in order (e.g., 30, 45, then 60 mg; or 45, 30, then 60 mg; or 45, 60 then 30 mg etc.).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MM 30mg; then MMS 45mg; then MMS 60mg<br>Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month | Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron<br>* MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron<br>* MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron<br>* MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>|
| Experimental: MM 30mg; then MMS 60mg; then MMS 45mg<br>Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month | Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron<br>* MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron<br>* MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron<br>* MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>|
| Experimental: MM 45mg; then MMS 30mg; then MMS 60mg<br>Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month | Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron<br>* MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron<br>* MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron<br>* MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>|
| Experimental: MM 45 mg; then MMS 60mg; then MMS 30mg<br>Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month | Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron<br>* MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron<br>* MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron<br>* MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>|
| Experimental: MM 60mg; then MMS 30mg; then MMS 45mg<br>Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month | Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron<br>* MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron<br>* MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron<br>* MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>|
| Experimental: MM 60mg; then MMS 45mg; then MMS 30mg<br>Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month | Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron<br>* MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron<br>* MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron<br>* MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of MMS formulations | To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot). | At one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Most preferred MMS formulation | To assess participated reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking them which supplement they like the best. | At three months | 
| Side effects of MMS formulations | To assess the occurance of side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires | At one month | 
| Adherence | Pill count of the number of supplements remaining at the end of one month | At one month | 
| Least preferred MMS formulation | To assess participated reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking them which supplement they like the least. | At three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptability, Multiple Micronutrient Supplementation, Iron, Tanzania