Effect of a Postpartum Multivitamin-Mineral Supplement on Maternal Nutrient Status and Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 12 weeks
Changes in serum Vitamin D (25-hydroxyvitamin D (25(OH)D) from baseline to end of intervention (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.
时间窗: 12 weeks
Changes in RBC Omega-3 (Total, DHA, and EPA) from baseline to end of intervention (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.
时间窗: 12 weeks
Changes in Iron status (serum iron, ferritin, TIBC, transferrin) from baseline to end of intervention (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.
时间窗: 12 weeks
Changes in serum B12 from baseline to end of intervention (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.
时间窗: 12 weeks
Iodine status measured as Maternal Urinary Iodine Concentrations + Creatinine at baseline and 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.
时间窗: 12 weeks
Changes in folate status (RBC folate) from baseline to end of intervention (12 weeks)
次要结局
- To assess the effects of the MVM supplement on changes in maternal mental health/wellbeing questionnaire among healthy, postpartum women.(12 weeks)