Efficacy of daily 4,000 International Units (IU) versus 6,000 IU of oral vitamin D3 in vitamin D deficient children with overweight and obesity: An open-label randomized controlled trial

IF 2.6 Q3 NUTRITION & DIETETICS

Clinical nutrition ESPEN Pub Date : 2025-06-09 DOI:10.1016/j.clnesp.2025.06.007

Priya Setia , Anju Seth , Ritu Singh , Rajeev Kumar Malhotra , Preeti Singh

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引用次数: 0

Abstract

Background and objectives

Children with overweight/obesity are at increased risk of vitamin D deficiency. This study compares the efficacy and safety of 4000 International Units (IU)/day vs. 6000 IU/day oral vitamin D₃ over 12 weeks for treating vitamin D deficiency and evaluates its impact on metabolic parameters.

Methods

In this open-label randomized controlled trial, 90 children (5–18 years) with overweight/obesity and vitamin D deficiency (25 [OH]D < 50 nmol/L) were randomized to receive 4000 IU/day (Group A, n = 45) or 6000 IU/day (Group B, n = 45) along with calcium. Efficacy (25 [OH]D ≥ 50 nmol/L), safety (hypercalcemia, hypercalciuria, hypervitaminosis D), and metabolic impact (HbA1c, lipids) were assessed over 12 weeks. Trial registered with CTRI/2021/02/031591.

Results

Sixty-eight children completed the study. Both groups showed significant increases in serum calcium and reductions in alkaline phosphatase and parathormone, with no inter-group differences. Group B showed a faster rise in 25(OH)D levels, with higher means at 4 weeks [66.3 (3.12) vs. 55.6 (2.92)] and 12 weeks [100.6 (3.42) vs. 79.3 (3.17) nmol/L]. At 12 weeks, sufficiency was achieved in 91.4 % (Group A) and 93.4 % (Group B). Mild, asymptomatic hypercalcemia was noted in 7 children (Group A-3, Group B-4; p = 0.70) and resolved spontaneously. No significant metabolic changes were observed in either group.

Conclusions

Both 4000 IU/day and 6000 IU/day of vitamin D₃ were effective and safe for treating vitamin D deficiency in overweight or obese children, with no observed effect on metabolic parameters in either group. Higher doses may accelerate sufficiency; however, standard dosing remains effective, emphasizing the need for individualized treatment and monitoring.

Impact statement

Comparing 4000 IU/day to 6000 IU/day of vitamin D₃ in children with overweight or obesity showed that both regimens were safe and effective in achieving sufficiency without either regimen influencing metabolic parameters. The higher doses allowed for a quicker attainment of optimal levels. While both doses effectively establish vitamin D sufficiency in the short term, long-term data are necessary to confirm their ongoing efficacy and safety over extended periods.

Clinical trial registration no

CTRI (Clinical Trial Registry India) (CTRI/2021/02/031591).

The protocol can be accessed at https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTI2NTM=&Enc=&userName=.

查看原文本刊更多论文

每日4,000国际单位（IU）与6,000国际单位口服维生素D3对超重和肥胖维生素D缺乏儿童的疗效：一项开放标签随机对照试验

背景和目的：超重/肥胖儿童维生素D缺乏症的风险增加。本研究比较了4000国际单位(IU)/天与6000国际单位/天口服维生素D3治疗维生素D缺乏症12周的疗效和安全性，并评估了其对代谢参数的影响。方法：在这项开放标签随机对照试验中，90名超重/肥胖和维生素D缺乏症（25[OH]D）的儿童（5-18岁）完成了研究。两组血清钙均显著升高，碱性磷酸酶和甲状旁腺激素均显著降低，组间差异无统计学意义。B组25(OH)D水平升高更快，4周时平均值更高[66.3（3.12）比55.6(2.92)]，12周时平均值更高[100.6（3.42）比79.3 (3.17)nmol/L]。12周时，91.4% （A组）和93.4% （B组）的充分性达到了。7例患儿出现轻度无症状高钙血症(A-3组，B-4组；P =0.70)，并自发溶解。两组均未观察到明显的代谢变化。结论：4000 IU/天和6000 IU/天的维生素D3治疗超重或肥胖儿童维生素D缺乏症是有效和安全的，对两组的代谢参数没有观察到影响。高剂量可能会加速充足；然而，标准剂量仍然有效，强调需要个体化治疗和监测。影响声明：比较超重或肥胖儿童4000 IU/天和6000 IU/天的维生素D3，两种方案都是安全有效的，在不影响代谢参数的情况下达到充足。较高的剂量可以更快地达到最佳水平。虽然这两种剂量在短期内都能有效地建立充足的维生素D，但需要长期数据来确认它们在长期内的持续有效性和安全性。临床试验注册号：CTRI（印度临床试验注册中心）（CTRI/2021/02/031591）该方案可在https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTI2NTM=&Enc=&userName=上访问。

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来源期刊

Clinical nutrition ESPEN NUTRITION & DIETETICS-

CiteScore

4.90

自引率

3.30%

发文量

512

期刊介绍： Clinical Nutrition ESPEN is an electronic-only journal and is an official publication of the European Society for Clinical Nutrition and Metabolism (ESPEN). Nutrition and nutritional care have gained wide clinical and scientific interest during the past decades. The increasing knowledge of metabolic disturbances and nutritional assessment in chronic and acute diseases has stimulated rapid advances in design, development and clinical application of nutritional support. The aims of ESPEN are to encourage the rapid diffusion of knowledge and its application in the field of clinical nutrition and metabolism. Published bimonthly, Clinical Nutrition ESPEN focuses on publishing articles on the relationship between nutrition and disease in the setting of basic science and clinical practice. Clinical Nutrition ESPEN is available to all members of ESPEN and to all subscribers of Clinical Nutrition.