4,000 IU of Vitamin D is too small a dose to help Obese - RCT Feb 2022

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Safety and tolerability of high-dose daily vitamin D3 supplementation in the vitamin D and type 2 diabetes (D2d) study—a randomized trial in persons with prediabetes

European Journal of Clinical Nutrition; https://doi.org/10.1038/s41430-022-01068-8
Karen C. Johnson, Anastassios G. Pittas, Karen L. Margolis, Anne L. Peters, Lawrence S. Phillips, Ellen M. Vickery, Jason Nelson, Patricia R. Sheehan, David Reboussin, Saul Malozowski, Ranee Chatterjee & D2d research group

Background/Objectives
Routine use of vitamin D supplements has increased substantially in the United States. However, the safety and tolerability of long-term use of high-dose vitamin D are not known. We assessed the safety and tolerability of high-dose, daily vitamin D3 in the vitamin D and type 2 diabetes (D2d) study.

Subjects/Methods
In total, 2423 overweight/obese persons with prediabetes were randomized in a double-blind manner to either 4000 IU of vitamin D3 (the tolerable upper intake level for adults by the National Academy of Medicine) taken daily or matching placebo. All participants were included in this analysis. Incident adverse events (AE) were ascertained 4 times a year at in-person visits (twice a year) and interim remote encounters (twice a year) and were defined as untoward or unfavorable medical occurrences. Serious adverse events (SAE) included death, life-threatening events, and hospitalizations.

Results
A total of 8304 AEs occurred during 3 years of follow-up and were less frequent in the vitamin D group compared to placebo (Incidence Rate Ratio [IRR] = 0.94; 95% Confidence Interval (CI) 0.90, 0.98). The overall frequency of protocol-specified AEs of interest, which included nephrolithiasis, hypercalcemia, hypercalciuria, or low estimated glomerular filtration rate, was low and did not differ by group. There were no significant between-group differences in total SAEs (IRR = 0.96 (0.81, 1.14)).

Conclusion
Vitamin D3 supplementation at 4000 IU per day was safe and well tolerated among overweight/obese participants at high risk for diabetes who were appropriately monitored for safety. In this population, this dose of vitamin D3 did not increase risk of AEs or SAEs, including those previously associated with vitamin D such as hypercalcemia, hypercalciuria, or nephrolithiasis.

ClinicalTrials.gov NCT01942694, prospectively registered September 16, 2013
 Download the PDF from VitaminDWiki

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Note: FEWER advese events in the Vitamin D group

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VitaminDWiki - Overview Obesity and Vitamin D contains

• FACT: People who are obese have less vitamin D in their blood
• FACT: Obese need a higher dose of vitamin D to get to the same level of vit D
• FACT: When obese people lose weight the vitamin D level in their blood increases
• FACT: Adding Calcium, perhaps in the form of fortified milk, often reduces weight
• FACT: 168 trials for vitamin D intervention of obesity as of Dec 2021
• FACT: Less weight gain by senior women with > 30 ng of vitamin D
• FACT: Dieters lost additional 5 lbs if vitamin D supplementation got them above 32 ng - RCT
• FACT: Obese lost 3X more weight by adding $10 of Vitamin D
• FACT: Those with darker skins were more likely to be obese Sept 2014
• OBSERVATION: Low Vitamin D while pregnancy ==> more obese child and adult
• OBSERVATION: Many mammals had evolved to add fat and vitamin D in the autumn
  • and lose both in the Spring - unfortunately humans have forgotten to lose the fat in the Spring
• SPECULATION: Low vitamin D might be one of the causes of obesity – several studies
• SUGGESTION: Probably need more than 4,000 IU to lose weight if very low on vitamin D due to
    risk factors such as overweight, age, dark skin, live far from equator,shut-in, etc.
• Obesity category has 442 items

See also: Weight loss and Vitamin D - many studies   Child Obesity and Vitamin D - many studies   Obesity, Virus, and Vitamin D - many studies
Obese need more Vitamin D

• Normal weight     Obese     (50 ng = 125 nanomole)

Click here for 2014 study

• Normal weight     Obese     (50 ng = 125 nanomole)

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VitaminDWiki - Obesity is associated with low Vitamin D (and treated by D as well) – Aug 2019 has

Fast weight loss by Obese Adults: Summary of the data as of Sept 2019
1) 50,000 IU Vitamin D weekly for at least 6 months
   If gut problems, should use a gut-friendly form of vitamin D
2) Add calorie restriction diet and light exercise after ~2 months*
   * Vitamin D levels must be above 30ng/ml to help with weight loss
   * Start losing weight 2 months sooner if take a 50,000 IU daily for a week
3) More weight loss if also add Magnesium or cofactors
   30% Improved Vitamin D response with Magnesium - a Vitamin D Cofactor
   Note: Magnesium reduces weight loss by itself as well
   20% improved vitamin D response if also add Omega-3 a Vitamin D Cofactor
  Note: Omega-3 reduces weight loss by itself as well
4) More weight loss if also improve activation of Vitamin D Receptor
   Vitamin D Receptor activator: 0-30% improved Vitamin D response
   Obesity 1.5 X more likely if poor Vitamin D Receptor – meta-analysis Nov 2019
Update Dec 2019 - Dr. Greger plant-based eating (not diet) for both weight loss and health.
  His book does not mention Vitamin D nor Adenovirus