Effect of Vitamin D3 Supplementation Over 25-hydroxivitamin D (25-OH-D) Status in Children From 12-30 Months of Age: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Chanche in 400UI,of vitamin D2 over 25-Hidroxi Vitamin D
研究概览
简要总结
Background Vitamin D (VD) is essential for calcium absorption, bone health and growth in children. In a national representative sample authors found mean serum concentration of 25-Hydroxi-Vitamin-D (25-OH-D) of 59 nmol/L, in children < 5 y of age. Prevalence deficiency of VD under 50 nmol/L was 33%, which means that 3 million preschool- age children have VD deficiency in Mexico. Additionally, less than 3% of the children use supplements with VD.
Objective To assess the effect of 400UI, 800IU of vitamin D2 and 1000IU of vitamin D3-colecalciferol- over 25-Hidroxi Vitamin D (25-OH-D) status and a multiple vitamin supplementation per day as a control group in children from 12-30 months of age in Cuernavaca, Morelos in a 4 month period.
Methods Randomized double blind parallel clinical trial, with vitamin D3 (colecalciferol) supplementation in 220 children from 12 - 30 months who attend day care centers.
Three supplementations will be given to children: 400IU and 800IU of vitamin D2, the third group 1000IU of D3-colecalciferol- and the control group will receive a multi vitamin supplementation. The duration of the intervention will be 16 weeks. Blood measurements would be taken at baseline, and at 16 weeks.
This study compares the efficacy of three dose of VD in children from 12-30 months of age, over the nutritional status of 25 hydroxivitamin D (25-OH-D). This intervention is of importance to establish supplementation strategies to prevent VD deficiency in Mexico.
Keywords: Vitamin D, nutritional deficiencies, micronutrients, children, México.
详细描述
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Objective. To assess the effect of 400UI, 800IU of vitamin D2 and 1000IU of vitamin D3-colecalciferol- over 25-Hidroxi Vitamin D (25-OH-D) status and a multiple vitamin supplementation per day as a control group in children from 12-30 months of age in Cuernavaca, Morelos in a 4 month period.
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Hypothesis Supplementation with 1,000 IU/d of vitamin D3-colecalciferol will have a greater effect on 25-OH-D concentrations compared to a dose of 400 IU and 800IU per day of vitamin D2 and will be more effective to decrease vitamin D deficiency in children from 12-30 months of age 4. Methods. 4.1 Study design. Factorial randomized double blind, parallel, controlled clinical trial with administration of a supplement containing 400IU or 800 IU of D2 or 1,000 IU of vitamin D3 -colecalciferol- and a multiple vitamin supplementation per day as a control group during a 4 month period.
Participants: A total of 220 children, both sexes, from 12-30 month of age will be studied (55 per treatment group).
Intervention period: 4 months Project duration: 18 months Place: Day Care centers(SEDESOL) in Cuernavaca, Morelos 4.2. Treatment: The Moses Oakford method will be used to assign the treatment. The scheme to randomize the sample will be by stratification and in blocks using a list of random numbers generated by a computer (STATA13). Stratification will be by age groups 12-18 months, 19-24 months and 25-30 months. Treatment will be assigned randomly to each supplement group. One group will receive 400IU of vitamin D2, the second group will receive 800 IU of D2, the third group will receive 1000IU of D3-colecalciferol- and the control group will receive a multi vitamin supplementation, that contains iron, vitamin A, C. E folic acid, niacin, and vitamins B1, B2, B6 y B12 The duration of the intervention will be 16 weeks.
4.3. Study Population- Children between 12 and 30 months of age, both sexes, which attend day care centers that are part of a national government program which main objective is to support working mothers and those who intend to work and do not have access to a health service. The program also includes single parents in charge of their family. Sample will be by convenience until sample is completed. Day care will be selected by convenience, (Principal interested in participating in the research project). A reunion will be made with authorities from SEDESOL and with the principals of the day care centers. The study objective, methodology and the importance of the project will be explained. After the meeting, a list of the day care centers who wish to participate will be made. A meeting with the parents will be assigned in order to explain the purpose, importance, objective and methods of the project.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The Moses Oakford method was used by an independent researcher to randomly assign each child to 1 of 3 groups to receive the administration of the three supplments. A computer was used to generate the random numbers (STATA v.13). Groups were stratified by age from 12- 18 months, from 19- 24 months and form 25- 30 months of age. Each block group was assigned 73 children.
入排标准
- 年龄范围
- 12 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children form 12-30 months of who attend the day care centers Children whose parents accepted their child to participate and sign the informed consent
排除标准
- •Children receiving multiple micronutrient supplementation/ other vitamin D suplement
- •Children whose parents did not accept to participate
- •Children with capillary hemoglobin concentration <9.0 g/dL at baseline
研究组 & 干预措施
Multiple vitamin
Children received 1 mililiter of a supplement with multiple vitamins (dosage applicator) frequency (daily) and duration 16 weeks
干预措施: Vitamin D (Dietary Supplement)
1000 IU vitamina D3
Children received 1drop (dosage applicator) containing 1000 IU of vitamin D3 per day. dosage form (1 drop), frequency (daily) and duration 16 weeks
干预措施: Vitamin D (Dietary Supplement)
800 IU7d vitmin D2
Children received 2 mililiter (dosage applicator) containing 800 IU of vitamin D2 per day. This suplement also contained: iron, vitamin A, C, and E, folic acid, niacin and vitamins B1, B2, B6 y B12. Vitamin D2, dosage form (1 mililiter), frequency (daily) and duration 16 weeks
干预措施: Vitamin D (Dietary Supplement)
400 IU/d vitamin D2
Children received 1mililiter (dosage applicator) containing 400 IU of vitamin D2 per day. This suplement also contained: iron, vitamin A, C, and E, folic acid, niacin and vitamins B1, B2, B6 y B12. Vitamin D2, dosage form (1 mililiter), frequency (daily) and duration 16 weeks
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Chanche in 400UI,of vitamin D2 over 25-Hidroxi Vitamin D
时间窗: Measurements were taken at baseline, and at 16 weeks
nmol/L
Chanche in 800UI,of vitamin D2 over 25-Hidroxi Vitamin D
时间窗: Measurements were taken at baseline, and at 16 weeks
nmol/L
Change in 1000 of vitamin D3 over 25-Hidroxi Vitamin D
时间窗: Measurements were taken at baseline, and at 16 weeks
nmol/L
次要结局
未报告次要终点
研究者
Mario Flores-Aldana
Mario Flores-Aldana, MD, PhD Nutrition Surveillance, Director
Instituto Nacional de Salud Publica, Mexico