Effect of Vitamin D on Cardiovascular Metabolic Risk in Overweight/Obesity Adolescents in China

Официальное название

The Improvement Effect of Vitamin D on the Cardiovascular Health of Overweight/Obesity Adolescents in China

Обзор

The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on cardiometabolic risk in Chinese adolescents with overweight/obesity and vitamin D deficiency. The main question it aims to answer whether vitamin D3 supplementation can improve cardiovascular metabolic health. Participants in the intervention group will receive vitamin D3. The control group will receive vitamin D placebo. Researchers will compare the change in cardiometabolic risk from baseline to post-intervention at 12 weeks between the intervention and control groups.

Подробное описание

Investigators will conduct a randomized controlled trial to examine whether vitamin D3 supplementation can improve cardiovascular metabolic health. A total of 130 participants will be recruited from two middle schools. Inclusion criteria were students with both students and parents signing a paper version of the informed consent form, overweight/obesity and serum 25(OH)D concentration of 12\~20ng/ml. Exclusion criteria are any disease that affects vitamin D metabolism (e.g., functional/organic brain disease, severe infectious disease, chronic gastrointestinal disease, hepatic or renal insufficiency, etc.); known chronic disease (e.g., cardiovascular disease); use of vitamin D supplements in the past 3 months; and adolescents with allergies to vitamin D or soybean oil ingredients. Participants will be randomly assigned into a supplementation or placebo group. Supplementation arm will receive oral dose 2000 IU vitamin D3 per day for 6 weeks and followed by 800 IU per day for 6 weeks, placebo arm will receive placebo every day for 12 weeks. For the first 6 weeks, vitamin D or placebo will be administrated every two weeks. For the next 6 weeks, vitamin D or placebo will be administrated every 3 weeks. The primary outcome of this study is to compare the change of cardiometabolic risk between supplementation or placebo group from post-intervention 12 weeks.

Вмешательства

• Препарат Dietary Supplement: Vitamin D3
  2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks.
• Препарат Dietary Supplement: Vitamin D3 placebo
  Three capsules for 6 weeks, followed by one capsule for 6 weeks.

Первичные конечные точки

• Change in cardiometabolic risk scores [Срок оценки: From randomization to the end of intervention at 3 months]

Вторичные конечные точки (5)

• BMI [Срок оценки: From randomization to the end of intervention at 3 months]
• Waist circumference and Sum of skinfold thickness [Срок оценки: From randomization to the end of intervention at 3 months]
• Blood pressure [Срок оценки: From randomization to the end of intervention at 3 months]
• Blood glucose and lipid [Срок оценки: From randomization to the end of intervention at 3 months]
• TyG index [Срок оценки: From randomization to the end of intervention at 3 months]

Критерии участия

Критерии включения

• Students whose caregivers signed informed consents;
• Students with serum 25(OH)D concentration of 12-20 ng/mL;
• Students with overweight or obesity.

Критерии исключения

• Students with any disease that affects vitamin D metabolism (e.g., functional/organic brain disease, severe infectious disease, chronic gastrointestinal disease, hepatic or renal insufficiency, etc.);
• Students with known chronic disease (e.g., cardiovascular disease); use of vitamin D supplements in the past 3 months;
• Students with allergies to vitamin D or soybean oil 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

Лечение

Центры проведения

Китай · 2 центра

• Anhui Medical University — Anqing
• Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07053657 · 81250471

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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