Mom Multi Postnatal Supplementation Trial

Официальное название

Effect of a Postpartum Multivitamin-Mineral Supplement on Maternal Nutrient Status and Wellbeing

Обзор

The goal of this clinical trial is to learn if a vitamin and mineral supplement designed specifically for women after childbirth can improve their nutrition and health in women who are pregnant or have recently given birth (within 6 weeks). The main question it aims to answer is: Can a postpartum-specific vitamin and mineral supplement help improve nutritional status and health outcomes in women after giving birth? Researchers will compare women who take the new postpartum vitamin and mineral supplement to women who take a placebo (fake pills without active ingredients) to see if the supplement improves their nutritional health. Participants will: Attend 2 visits at University of Georgia (1-1.5 hours each) over 12 weeks Participate in 2 phone calls between visits Stop taking other vitamin/mineral supplements during the study Have blood drawn to test vitamin and mineral levels Provide urine samples and breastmilk samples if breastfeeding (optional) Have height, weight, and skin color measured Complete questionnaires about health, pregnancy, and mental wellness Answer questions about daily food and drink intake Take either the study supplement or placebo daily

Вмешательства

• Пищевая добавка Perelel Mom Multi
  Daily Perelel postnatal multivitamin supplement throughout intervention
• Пищевая добавка Placebo
  Daily placebo capsules throughout intervention

Первичные конечные точки

• To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal Vitamin D status as compared to placebo among healthy, postpartum women. [Срок оценки: 12 weeks]
• To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal iron status as compared to placebo among healthy, postpartum women. [Срок оценки: 12 weeks]
• To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal Vitamin B12 status as compared to placebo among healthy, postpartum women. [Срок оценки: 12 weeks]
• To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal iodine status as compared to placebo among healthy, postpartum women. [Срок оценки: 12 weeks]
• To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal Omega-3 status as compared to placebo among healthy, postpartum women. [Срок оценки: 12 weeks]
• To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal folate status as compared to placebo among healthy, postpartum women. [Срок оценки: 12 weeks]

Вторичные конечные точки (1)

• To assess the effects of the MVM supplement on changes in maternal mental health/wellbeing questionnaire among healthy, postpartum women. [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Healthy, postpartum women (\~4 weeks \[± 2 weeks\]) with infants born term and singleton
• Not pregnant during the study period
• Able to understand (written and spoken) English or Spanish.

Критерии исключения

• Cardiometabolic disease
• Past pregnancy complications (gestational diabetes, hypertension)
• malabsorption syndromes (IBS, IBD, Crohn's, Colitis, Celiac)
• Caily use of medications which may affect nutrient absorption
• chronic alcohol use (> 4 alcoholic drinks/day)
• those prescribed postnatal MVM supplements by their physician
• unwilling to discontinue dietary supplementation containing any of the active components in the study product over the study period
• Women should not have an allergy or intolerance to active or inactive product ingredients.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• UGA Clinical & Translational Unit — Athens

Идентификаторы

NCT: NCT07303595 · PROJECT00012011 · Sponsor

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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