Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| INV-071025 | Other Grant/Funding Number | Gates foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
MEDHA is a randomized controlled trial among 10-18 year old girls to examine the use-case of the United Nations International Multiple Micronutrient Antenatal Preparation Multiple Micronutrient Supplements (UNIMMAP) multiple micronutrient supplement (MMS) formulation and to test an enhanced regimen (MMS+) with additional nutrients, vs. weekly iron-folic acid as standard of care on outcomes of neurodevelopment, linear growth, biochemical status, bone health, and other functional and health outcomes. This study is an individually randomized, placebo-controlled, three-arm trial of 3,000 participants supplemented for 12 months to assess the efficacy and safety of nutrient supplementation. Results of the study will inform the design of nutritional interventions and policy for this age group. In the context of the trial, the investigators will also do in-depth clinical and health assessments and collect biospecimens for a bio-archive for future deep-phenotyping of this population. This study will be conducted at the Johns Hopkins Bangladesh JiVitA field site in rural Gaibandha District of Bangladesh.
Adolescents (10-19 year olds) are an understudied group despite increasing numbers in many regions, especially in low- and middle-income countries (LMICs). Numerous reviews on adolescent health and nutrition have identified major data gaps for this population, including lack of information on the nutritional challenges and the burden of existing deficiencies adolescents face and uncertainty about the level of nutritional support required during this period of rapid physical and cognitive development during and following puberty. The consequences of poor adolescent nutrition for reproductive health and survival as well as bone health in later life among females calls for special attention to vulnerable girls in LMICs.
The primary aim of this study is to determine the efficacy of daily supplementation with MMS (using the UNIMMAP formulation) and an enhanced regimen (MMS+) composed of UNIMMAP plus additional nutrients (calcium, choline, docosahexaenoic acid -DHA, and higher amount of vitamin D) vs. weekly iron-folic acid (IFA) alone on a range of neurodevelopment, biochemical, linear growth and functional outcomes among 10-18 year old girls in rural Bangladesh. The investigators hypothesize that daily MMS or MMS+ will result in an improvement for the co-primary outcomes of school achievement and physical growth (HAZ), and secondary functional outcomes including neurocognitive function, bone health, and biochemical nutrient status among adolescents following 6 and 12 months of supplementation compared with weekly IFA supplementation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron (60 mg)- folic acid (400 ug) [IFA] | Active Comparator | Weekly IFA will be provided in the control arm as standard-of-care for a year as per government of Bangladesh policy and WHO guidelines for this age group. |
|
| Multiple micronutrient supplement [MMS] | Experimental | A daily MMS supplement containing 15 micronutrients using the UNIMMAP (United Nations International Multiple Micronutrient Antenatal Preparation) formulation. This will be provided in a daily tablet form for a year. |
|
| Multiple micronutrient supplement Plus [MMS+] | Experimental | MMS+ will be a package of nutrient supplements comprising the UNIMMAP tablet, plus a lipid-based chickpea product with choline, calcium and additional vitamin D, plus a local DHA/EPA softgel taken daily for a year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron (60 mg)- folic acid (400 ug) [IFA] | Dietary Supplement | Weekly IFA will be provided in the control arm as standard-of-care for a year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wide Range Achievement Test (WRAT-5) Composite Score | The Wide Range Achievement Test assess reading, writing and arithmetic and is a school achievement test. The total score on this test will be used. The mean for the total composite score is 100 and SD is 15. Most scores fall between 70 and 130, with higher scores indicating above-average achievement and lower scores indicating below-average achievement | WRAT-5 will be administered at baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits. |
| Height-for-age Z score | Height will be assessed and expressed as a Z-score using reference standards for children. Stunting will be defined using HAZ < -2. | Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits |
| Measure | Description | Time Frame |
|---|---|---|
| WRAT-5 math, reading and spelling scores | Individual domain scores derived from the WRAT-5. The mean for each is approximately 70 with SD of 20. | Baseline, midline (6 months) and endline (12 months) |
| General Intelligence as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI-II) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Parul Christian, DrPH | Contact | 14109552061 | pchrist1@jhu.edu | |
| Daniel Erchick, PhD | Contact | derchick@jhu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Parul Christian, DrPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JiVitA Project Head Quarters | Rangpur City | Bangladesh |
Not provided
Not provided
Not provided
Not provided
Given the nature of the three types of interventions, and their taste and the regimen, and difficulty in creation of true placebos, this trial will not be masked. Those providing the intervention will be a separate cadre of community workers than the data collection teams.
Not provided
| Multiple micronutrient supplement [MMS] | Dietary Supplement | Experimental: Multiple micronutrient supplement [MMS] A daily MMS supplement containing 15 micronutrients using the UNIMMAP (United Nations International Multiple Micronutrient Antenatal Preparation) formulation. This will be provided in a daily tablet form for a year. |
|
| Multiple micronutrient supplement Plus [MMS+] | Dietary Supplement | Experimental: Multiple micronutrient supplement Plus [MMS+] MMS+ will be a package of nutrient supplements comprising the UNIMMAP tablet, plus a lipid-based chickpea product with choline, calcium and additional vitamin D, plus a local DHA/EPA softgel taken daily for a year. |
|
This will be assessed using Wechsler Abbreviated Scale of Intelligence (WASI-II). The full scale IQ has a mean (SD) of 75 (12). |
| Baseline (presupplementation) and endline (12 months) |
| Executive function as assessed by the Digit Span | Assessed using Digit Span | Baseline and Endline (12months) |
| Executive function as assessed by the Number Stroop | Assessed using Number Stroop | Baseline and Endline (12months) |
| Motor function standardized score as assessed by Movement Assessment Batter for Children - 3 | Using Movement Assessment Battery for Children -3. Standardized scores for Pegboard, Manual Dexterity, and Balance will be used. Task scores have a mean (SD) of 10(3). | Baseline and endline (12months) |
| Bone mineral density | Radiography of radius and tibia | Baseline and Endline (12 months) |
| Body mass index Z-score | BMIZ score will be derived using weight and height measurements using reference standards. BMIZ < 2 is used to define underweight. | At Baseline (pre-supplementation), midline (6 months) and 12 (months) |
| Nutrient status | Assessed using blood serum/plasma, or urine (vitamin A, D, E, B12, zinc, Hb, iodine, Thyroglobulin) | Baseline (pre-supplementation) and Midline (6 months) |
| Endocrine factors | Leptin, Estradiol, Osteocalcin | Baseline (pre-supplementation) and midline (6 months) |
| Health-related Quality of Life (HRQoL) | The HRQoL; (EQ-5D-5L) will be used. | At baseline and endline (12 months) |
| Blood Pressure (mmHg) | Blood pressure - systolic and diastolic BP (mm Hg) taken using a BP monitor. | Baseline (pre-supplementation), midline (6 months) and endline (12 months) |
| % Fat free mass | Body composition will be assessed using anthropometry and skinfold measurements | Baseline (presupplementation), midline (6 months) and endline (12 months) |
| Waist-to-Height Ratio | Waist circumference and height will be assessed to derive this ratio | Baseline (presupplementation), midline (6months) and endline (12 months) |
| Hand grip strength | Using kg pressure | Baseline (presupplementation), midline (6months), endline (12 months) |
| Conners Parent Rating Scale Scores | These standardize scales will be administered to assess behavioral disorders among children. | Baseline and Endline (12 months) |
| ID | Term |
|---|---|
| D013851 | Thinness |
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D007501 | Iron |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided