Clinical trial NCT06081114: Micronutrient Dose Response Study in Bangladesh
Official title: Micronutrient Dose Response (MiNDR) Study in Bangladesh
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Micronutrient Status
Keywords: Pregnancy
Micronutrients
Energy
Supplements
Biochemical indicators
protein
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: International Center for Diarrheal Disease Research, Bangladesh (icddr,b)
name: Bill and Melinda Gates Foundation
First posted: 2023-10-13
Enrollment: 650
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: The primary aims of the study are to:

1. To characterize the time-course of in vivo exposures (dose response) of several micronutrients in pregnant and non-pregnant and non-lactating women of reproductive age (WRA) in a real-life situation.
2. To characterize any clinically meaningful prognostic factors that can explain the between-subject variability.
3. To investigate whether the micronutrients follow dose-proportional pharmacokinetics.

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

Primary outcomes:
measure: Change in vitamin A status
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in vitamin D status
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in vitamin E status
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in B-vitamin static indicators
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in B-vitamin enzymatic activity
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in iron status
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in iodine status
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in selenium static indicator
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in selenium enzymatic indicator
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in zinc status
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
Secondary outcomes:
measure: Changes in inflammation
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in hormonal markers
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in clinical markers of liver enzymes
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in clinical markers of lipid profile
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in clinical markers of renal function
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in clinical markers of electrolytes
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in glucose
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in hemoglobin
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in serum minerals
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in bone turnover biomarker
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
measure: Change in urinary metabolite of vitamin E
timeFrame: Baseline, midline, end-line, up to 1 month post-partum (Pregnant women). Baseline, midline, end-line, up to 3 months (non-pregnant women)
Other outcomes:
measure: Number of participants with side effects
timeFrame: Weekly from enrollment up to 1 month postpartum for pregnant women. Weekly from enrollment up to 3 months for non-pregnant women
measure: Breastmilk Vitamin A concentration
timeFrame: 1 month postpartum
measure: Breastmilk Vitamin E concentration
timeFrame: 1 month postpartum
measure: Breastmilk B vitamin concentration
timeFrame: 1 month postpartum
measure: Breastmilk mineral concentration
timeFrame: 1 month postpartum
measure: Change in gut microbiome composition
timeFrame: Baseline, end-line up to 36 wks of gestation in pregnancy (Pregnant women). Baseline, end-line up to 3 months (non-pregnant women)
measure: Frequency of neonatal deaths across study arms
timeFrame: Birth to 28 days of life
measure: Frequency of stillbirths across study arms
timeFrame: At birth
measure: Frequency of low birth weight infants across study arms
timeFrame: At birth
measure: Frequency of preterm birth across study arms
timeFrame: At birth
measure: Frequency of gross congenital defects across study arms
timeFrame: At birth
measure: Frequency of neonatal morbidity across study arms
timeFrame: At 1 month of age
measure: Change in infant gut microbiome composition, functional profile and maturation
timeFrame: 3-6 months and 6-9 months of infant age
measure: Change in human milk oligosaccharide composition
timeFrame: 1 month, 3-6 months and 6-9 months of infant age
measure: Infant length-for-age z-score
timeFrame: 3-6 months and 6-9 months of infant age
measure: Infant weight-for-length z-score
timeFrame: 3-6 months and 6-9 months of infant age
Locations:
city: Rangpur
country: Bangladesh
facility: JiVitA Project
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Parul Chrisian, DrPH
role: PRINCIPAL_INVESTIGATOR
References: