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NCT06081114
Micronutrient Dose Response Study in Bangladesh
Conditions: Micronutrient Status
Sex: Female
Ages: 18 Years – 35 Years
Healthy volunteers: No
Phase: NA
Enrollment: 643
Sponsor: Johns Hopkins Bloomberg School of Public Health
Location: JiVitA Project Rangpur City
Summary
The recommended daily amounts of vitamins and minerals, referred to as micronutrients, are based on data from high income settings and for healthy populations do not fully correct nutritional deficiencies in undernourished settings. This study will determine the minimum acceptable doses across a range of nutrients at which sufficiency is achieved with supplementation using biochemical indicators of nutritional status in non-pregnant (non-lactating) women of reproductive age and pregnant women in Bangladesh. In this double-masked randomized controlled trial, a dose response study will be undertaken using increasing levels of doses provided as supplements to women (pregnant or non-pregnant) with nutritional indicators as outcomes.
Eligibility Criteria
Inclusion Criteria:
Either
* Women (non-pregnant and non-lactating) and not planning a pregnancy in the next 6 months
OR
* Pregnant women (gestational age at enrollment of 12-14 weeks)
Exclusion Criteria:
* Eligible women not consenting to participate
* Based on point-of-care clinical indicators after enrollment and prior to starting the intervention that is indicative of pre-existing liver or kidney conditions and severe anemia
Source: ClinicalTrials.gov (NCT06081114). StuddyBuddy aggregates publicly available trial information.